Atlas FDA

KSR

16 FDA 510(k) clearances · Product code

92 daysmedian time to decision
177 days90th percentile
16clearances measured

FDA profile

Official device name
Container, Empty, For Collection & Processing Of Blood & Blood Components
Device class
Class II (moderate risk)
Regulation
21 CFR 864.9100
Medical specialty
Hematology
Adverse events (MAUDE)
2014: 11 · 2015: 8 · 2020: 21 · 2021: 17 · 2023: 20 · 2024: 25
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501 (K032827)Tyco Healthcare2003-12-08
DEROYAL SURGICAL, UMBILICUP (K020753)Deroyal2002-06-13
ALPHA PLASTIC PLASMA BOTTLE (K810897)Alpha Therapeutic Corp.1981-09-23
BLOOD FREEZING BAG (K810500)Delmed, Inc.1981-09-23
PLASMA FLEX (K811523)Terumo America, Inc.1981-09-09
HAEMONETICS 1000ML COMPONENT BAG (K811449)Haemonetics Corp.1981-07-01
HAEMONETICS 600 ML. COMPONENT BAG (K810711)Haemonetics Corp.1981-05-08
HAEMONETICS 1400 ML THERAPEUTIC BAG (K810313)Haemonetics Corp.1981-03-31
GAMBRO HEMOFREEZE-BAG (K801082)Gambro, Inc.1980-10-31
PLASMAPOOLER (K801219)North American Biologicals, Inc.1980-10-31
PHARMAFLEX CRYOGENIC BAG (K792395)Pharmachem Corp.1980-02-26
PIASMA SAFE (K792185)Cry-O-Safe, Inc.1979-12-28
EMPTY TRANSFER BAG (K791673)Delmed, Inc.1979-10-23
TRANSFER PAK 4R 9006 (K781811)Travenol Laboratories, S.A.1978-11-08
CRYOCYTE PACK (K780354)Travenol Laboratories, S.A.1978-06-14
TERASAKI LYMPHOCYTE TRANSPORT KIT (K760952)Dravon Medical, Inc.1977-01-17

Track KSR automatically

Every clearance here is in the API, with alerts when new ones post.