FDA product code KSR: Container, Empty, For Collection & Processing Of Blood & Blood Components
KSR is the FDA product code for container, empty, for collection & processing of blood & blood components. It is a Class II device, regulated under 21 CFR 864.9100 and reviewed by the Hematology panel. FDA has cleared 16 510(k) submissions under KSR, from 12 different applicants. The average 510(k) review took 97 days (median 90). FDA has posted 4 recalls for KSR devices.
Classification
| Field | Value |
|---|---|
| Device name | Container, Empty, For Collection & Processing Of Blood & Blood Components |
| Device class | Class II |
| Regulation | 21 CFR 864.9100 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every KSR clearance
Top KSR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Haemonetics Corp. | 3 | 1981-07-01 |
| Delmed, Inc. | 2 | 1981-09-23 |
| Travenol Laboratories, S.A. | 2 | 1978-11-08 |
| Tyco Healthcare | 1 | 2003-12-08 |
| Deroyal | 1 | 2002-06-13 |
7 more applicants have KSR clearances. See the full list in Caduvo.
Most recent KSR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K032827 | Tyco Healthcare | KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501 | 2003-12-08 | 89 |
| K020753 | Deroyal | DEROYAL SURGICAL, UMBILICUP | 2002-06-13 | 98 |
| K810500 | Delmed, Inc. | BLOOD FREEZING BAG | 1981-09-23 | 211 |
| K810897 | Alpha Therapeutic Corp. | ALPHA PLASTIC PLASMA BOTTLE | 1981-09-23 | 173 |
| K811523 | Terumo America, Inc. | PLASMA FLEX | 1981-09-09 | 103 |
Recalls for KSR devices
4 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-01-20.
Frequently asked questions
What is FDA product code KSR?
KSR is the FDA product code for container, empty, for collection & processing of blood & blood components. It is a Class II device, regulated under 21 CFR 864.9100 and reviewed by the Hematology panel.
What device class is KSR?
Class II, regulation 21 CFR 864.9100. Typical premarket route: 510(k).
How long does a 510(k) take for product code KSR?
Across 16 cleared submissions the average was 97 days from receipt to decision (median 90).
Which companies have the most KSR clearances?
Haemonetics Corp. (3); Delmed, Inc. (2); Travenol Laboratories, S.A. (2); Tyco Healthcare (1); Deroyal (1).
Have KSR devices been recalled?
Yes: 4 product recalls across 3 recall events; the most recent began 2012-01-20.
Next steps
- Run an FDA pathway report with predicate devices for product code KSR
- Run a recall and safety report across every KSR manufacturer
- Watch product code KSR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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