Product code KME— General Hospital
DISPOSABLE PILLOW
- Classification name
- Bedding, Disposable, Medical
- Device class
- Class 1
- Regulation
- 21 CFR 880.6060
- Advisory panel
- General Hospital
- Total cleared
- 65
- First cleared
- Most recent
Market context for product code KME
FDA has cleared devices under product code KME between 1976 and 2004, filed by 46 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
last 15 years- 2004
- 1994
- 1993
- 1992
- 1991
- 1990
- 1989
- 1988
- 1987
- 1986
- 1985
- 1984
- 1982
- 1981
- 1980
Top applicants under product code KME
Recent clearances under product code KME
- K042145 — READY-HEAT BLANKET
- K944953 — OREX MEDICAL BEDDING
- K933636 — DISPOSE-A-SHEET
- K932539 — DOCTOR DOWN --RESCUE WRAP
- K922143 — AMERICAN BURN SHEET
- K915303 — FOIL BABY BUNTING
- K912257 — CHEM-SLEEVE B
- K911948 — MEDI GUARD PILLOWCASE
- K911952 — MEDI GUARD UNDERPAD
- K911953 — MEDI GUARD SHEETS/UNDERLAYS
- K911950 — MEDI GUARD DRAPES
- K905003 — BIO-GUARD SHAVE PREP TRAY
- K904274 — RECEIVING BLANKET
- K901509 — TRAUMA SLEEVE
- K901629 — CHEM-SLEEVE
- K900643 — FLUID SOAKERSHIELD
- K896043 — MATTRESS COVER FOR MEDICAL PURPOSES
- K891986 — MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE
- K894170 — DEVON DISPOSABLE HEAD POSITIONER COVER
- K884380 — BED SHEET, PILLOW CASE
- K882332 — HEADREST, PATIENT COMFORT
- K881969 — DRY COMFORT DISPOSABLE UNDERPAD
- K881859 — DRIPRIDE DISPOSABLE UNDERPAD
- K871725 — DRIPRIDE DISPOSABLE UNDERPADS
- K870925 — PAD, BED LINEN PROTECTIVE
- K870522 — DEPEND UNDERPAD
- K864158 — THERMAPAD
- K863179 — KIMLON DISPOSABLE BLANKET
- K862348 — SINGLE-USE PATIENT UNDERPAD
- K860066 — REFLECTIVE BLANKET
- K853970 — ALPHA CHUCK
- K853880 — ATTENDS DISPOS. UNDERPAD
- K850067 — MEDICAL, DISPOSABLE BEDDING
- K850811 — PAD, PRE-OPERATIVE PREPARATION
- K850544 — SHAVE PREP TRAY
- K842989 — SHAVE PREP KITS
- K844196 — WET SKIN SCRUB TRAY STERILE WET SKIN SCRUB KIT
- K843038 — DISPOSABLE PATIENT BLANKET
- K843402 — MOLINEA UNDERPADS
- K842335 — PILLOW W/STAPHCHEK TICKING
- K842336 — DISPOSABLE PILLOW
- K832486 — PILLOW COVER, ANTI-MICROBIAL
- K832487 — DRAW SHEET, ANTI-MICROBIAL
- K822650 — SUPER DONUT
- K821835 — BARRIER BURN SHEET
- K820582 — 3M THINSULATE DISPOSABLE HOSPITAL BED
- K813519 — NON-ABSORBENT TOWELS
- K813263 — PATIENT UNDERPAD
- K812079 — DISPOSABLE PILLOW
- K811232 — DISPOSABLE UNDERPADS
- K810264 — DISPOSABLE PILLOW
- K802998 — PATIENT CARE DISPOSABLE INFANT SHIRTS
- K802730 — FLUFF UNDERPAD TYPE UP1002
- K802740 — FLUFF UNDERPAD TYPE UP1001
- K792626 — STERILIZATION PROCESS/BABY BLANKET
- K790411 — AUTO TRAUMA KIT
- K790659 — INFANT SCALE DISPOSABLE LINER
- K790283 — PILLOW, CARTER ARM ELEVATION
- K781796 — BEDDING, DISPOSABLE HOSPITAL
- K782001 — ROSEALAE
- K781227 — TOWELS, SHEETS, PILLOWCASES
- K781354 — PILLOWS- SINGLE PATIENT USE
- K770486 — SHEET KIT, STRETCHER, DISPOSABLE
- K761108 — PLASTIC DISPOSABLE BIB
- K761109 — TERRYCLOTH BIBS
Data sourced from openFDA. This site is unofficial and independent of the FDA.