Product code FNL— General Hospital
PREMISE SERIES BED
- Classification name
- Bed, Ac-Powered Adjustable Hospital
- Device class
- Class 2
- Regulation
- 21 CFR 880.5100
- Advisory panel
- General Hospital
- Total cleared
- 70
- First cleared
- Most recent
Market context for product code FNL
FDA has cleared devices under product code FNL between 1978 and 2021, filed by 41 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2021
- 2010
- 1998
- 1997
- 1996
- 1995
- 1994
- 1993
- 1992
- 1991
- 1990
- 1989
- 1988
- 1987
- 1986
Top applicants under product code FNL
Adverse events under product code FNL
product code FNL- Death
- 64
- Injury
- 728
- Malfunction
- 10,825
- Other
- 9
- Total
- 11,626
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code FNL
- K202964 — iBed Wireless with iBed Mobile
- K103536 — IBED WIRELESS WITH IBED AWARENESS
- K982783 — VAIL 1000 ENCLOSED BED
- K974296 — MODEL 720 SERIES FULL/SEMI ELECTRIC BED 1120 FULL ELECTRIC BED
- K974254 — BENEFIT B3--- SERIES
- K972115 — VOLKER HOSPITAL BED, MODEL K960
- K971546 — SOMA 900 TRANSPORT BED
- K963622 — VAIL 2000 ENCLOSED BED
- K963589 — VAIL 3000 BED ENCLOSURE
- K962942 — TOTALCARE
- K963701 — SOMA SAFE ENCLOSURE
- K964246 — NOVABED PATIENT TRANSFER SYSTEM
- K964515 — ACCLAIM SERIES QD6000,QD6001,QD6002 AND SERIES QD3000,QD3001, QD3002
- K962250 — CARROLL HEALTHCARE DLX 2300-111 ELECTRIC BED
- K962763 — 2000 MODULAR THIRTY-NINE
- K951514 — SSC MODEL 4000 SERIES
- K951735 — JOERNS HEALTHCARE, INC. FULL LENGTH TELESCOPING RAIL
- K951161 — MC ACCLAIM Q6000 BED
- K945042 — ELITE 3 LOW AIR LOSS BED
- K946149 — STRYKER AGILITY INTENSIVE CARE BED
- K946208 — VOLKER NURSING BED MODEL 2080E & 2090E
- K945664 — BARIKARE PLUS
- K935837 — AIRHYTHM HEALTHCARE BED
- K934090 — S.S.C. MEDICAL MODEL 5000 SERIES BED
- K932663 — MEDLINE A/C POWERED HEALTHCARE BEDS & ACCESSORIES
- K930703 — ADJUSTABLE BED
- K931581 — GLENN BED
- K931482 — STRYKER MPS ACUTE CARE BED
- K926435 — COMFORTADE
- K930234 — FLH1768M SERIES HOSPITAL BED
- K925576 — BURKE BARIATRIC TREATMENT SYSTEM II
- K925534 — FULL/SEMI ELECTRIC HOME CARE BED
- K922352 — THE ADVANCE SERIES FROM HILL-ROM
- K915437 — CRITICAL CARE HOSPITAL BED (ICU/CCU)
- K911893 — EASY ACCESS BED
- K903904 — SERIES 2000 ADJUSTABLE BED
- K902183 — S.S.C. MEDICAL PRODUCTS HOME HEALTH CARE BED
- K900151 — INVACARE EXTENDED CARE NURSING HOME BED
- K893745 — THE INDEPENDENT CARE UNIT
- K894296 — PREMISE SERIES BED
- K890845 — PREMISE SERIES BED
- K890293 — AIDE-A-PATIENT (NURSING HOME BED)
- K890426 — CONSUMMATE AIR THERAPY BED
- K881960 — MSI STANDARD BED MODELS L1098-84/L1098-74/L1085-74
- K883463 — HOSPITAL BED CLOTHING CRADLE
- K881844 — MAGNUM 800(TM) MANAGEMENT SYSTEM
- K881782 — MSI 4000 SERIES BED
- K881963 — MSI 3002 SERIES BED
- K881965 — MSI 5000 SERIES BED
- K881027 — MSI 2002 SERIES BED
- K875037 — STRYKER 1990 LIBERTY ELECTRIC CRITICAL CARE BED
- K873291 — MSI 9000 SERIES BED
- K872923 — PARAGON 9000 TILT AND TURN BED
- K872924 — PARAGON 8500 CARDIO-PULMONARY BED
- K872925 — MEGABED 1000
- K864172 — HILL-ROM CENTURY CC, MODELS 891 & 893 WEIGHING SYS
- K864186 — HILL-ROM CENTURY CC MODELS 892 &894 (RADIOLUCENT)
- K854832 — EVEREST & JENNING SERIES 5000 MODULAR BED
- K854867 — EVEREST & JENNINGS TRADITION-STANDARD BED L109684&
- K854937 — CARROM CARELIFE SERIES 40000 MODULAR BES SYSTEM
- K853270 — CENTERCOM CONTROL
- K852674 — STRYKER 988 ICU BED
- K851551 — MERIVAARA ELECTRIC HOSPITAL BED & ACCESSORIES
- K843781 — KINAIR, LOW AIR LOSS BED
- K831821 — PNEUMATIC/ELECTRIC/HYDRAULIC BED
- K830559 — HEALTHCARE MODEL #175/176 BED SERIES
- K821185 — NEW SUPPORT SYS. FOR BEDRIDDEN PATIENTS
- K811897 — LIC TURNOVER BED
- K790049 — BED, PARAPLEGIC
- K780371 — TILT TYPE AC POWERED HOSPITAL BED
Data sourced from openFDA. This site is unofficial and independent of the FDA.