510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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KSRClass II

Container, Empty, For Collection & Processing Of Blood & Blood Components

21 CFR 864.9100 / Hematology
FDA source (opens on fda.gov)

KSR is the FDA product code for Container, Empty, For Collection & Processing Of Blood & Blood Components, a class II device type, regulated under 21 CFR 864.9100. As of , FDA records hold 16 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
KSR
Device name
Container, Empty, For Collection & Processing Of Blood & Blood Components
Regulation
21 CFR 864.9100
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
16
Ingested recalls
4

Clearances, product code KSR

By decision year
16 clearances under product code KSR with a decision year between 1977 and 2003, 1981 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code KSR by decision year
YearClearances
19771
19782
19792
19803
19816
20021
20031

Applicants with the most clearances

Product code KSR
Applicants holding the most 510(k) clearances under product code KSR
ApplicantClearances
Haemonetics Corporation3
Delmed, Inc.2
Travenol Laboratories, S.A.2
Alpha Therapeutic Corp.1
Cry-O-Safe, Inc.1
Deroyal1
Dravon Medical, Inc.1
Gambro, Inc.1
North American Biologicals, Inc.1
Pharmachem Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 23 companies shown, in name order