Product code CAK— General Hospital
20 MICRON HIGH CAPACITY TRANS/FILTER
- Classification name
- Microfilter, Blood Transfusion
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Total cleared
- 36
- First cleared
- Most recent
Market context for product code CAK
FDA has cleared devices under product code CAK between 1976 and 2006, filed by 20 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- 2006
- 2002
- 2000
- 1999
- 1998
- 1997
- 1996
- 1990
- 1989
- 1988
- 1987
- 1986
- 1985
- 1983
- 1981
Top applicants under product code CAK
Adverse events under product code CAK
product code CAK- Malfunction
- 476
- Total
- 476
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 CAK
- K061103 — HAEMONETICS 40U RBC FILTER BAG
- K022477 — SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SET
- K000719 — NEOCARE 20 MICRON BLOOD FILTER
- K990310 — CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER)
- K982822 — FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72
- K972159 — FENWAL 40 MICRON TRANSFUSION FILTER
- K970225 — ALPHA MICRON 20/40 MICROAGGREGATE FILTER
- K960993 — PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST)
- K955515 — ALPHA MICRON 20 MICROAGGREGATE FILTER
- K904221 — SEPACELL(R) PL-5A/10A LEUKOCYTE REMOVAL FILTERS
- K904223 — SEPACELL(R) R-200/500 LEUKOCYTE REMOVAL RECIP SETS
- K901887 — MODIFIED SEPACELL R-SERIES BLOOD FILTERS
- K896203 — SOLCOSEPT(TM) BLOOD TRANSFUSION FILTER
- K896664 — MODIFIED SEPACELL PL-SERIES LEUKOCYTE REMOVAL FILT
- K896976 — MODIFIED SEPACELL R-500 AND R-500A BLOOD FILTERS
- K890844 — MICROSEPT 60/20
- K873792 — SEPACELL R-500 AND SEPACELL R-500A
- K873666 — PALL LEUKOCYTE REMOVAL FILTER, BLOOD
- K873667 — PALL LEUKOCYTE REMOVAL FILTER, PLATELETS
- K873873 — RESUBMITTED MICRON TRANSFUSION FILTER
- K864636 — ERYPUR B
- K855064 — SWANK BLOOD TRANSFUSION MICRO-FILTER W/STRAIGHT SE
- K854259 — SEPACELL R-500 & SEPACELL R-500A
- K851370 — INTERFACE TRANSFUSION BLOOD FILTER #35
- K830057 — 20 MICRON HIGH CAPACITY TRANS/FILTER
- K830014 — HEMA - NV TRANS. BLOOD FILTER 100/800
- K823261 — INTERFACE TRANSFUSION BLOOD FILTER #30
- K812874 — PEDIATRIC MICROAGGREGATE BLOOD FILTER
- K812697 — HEMA 20 MICRON TRANSFUSION BLOOD FILTER
- K811985 — ULTIPOR SQ40S BLOOD TRANSFUSION FILTER
- K810761 — ALPHA MICRON-40 FILTER
- K810855 — INTERFACE 20 MICRON TRANSFUSION BLD. F.
- K780145 — BLOOD FILTER, MICROEMBOLI-ATS-F10
- K770253 — MICROFILTRATION SET MF10
- K760165 — FILTER, INFUSION BLOOD (1 PFF-100)
- K760222 — FILTER, TRANSFUSION BLOOD, INTERSEPT
Data sourced from openFDA. This site is unofficial and independent of the FDA.