FDA product code KIR: Cells, Animal And Human, Cultured
KIR is the FDA product code for cells, animal and human, cultured. It is a Class I device, regulated under 21 CFR 864.2280 and reviewed by the Pathology panel. FDA has cleared 170 510(k) submissions under KIR, from 18 different applicants. The average 510(k) review took 75 days (median 56). FDA has posted 1 recall for KIR devices.
Classification
| Field | Value |
|---|---|
| Device name | Cells, Animal And Human, Cultured |
| Device class | Class I |
| Regulation | 21 CFR 864.2280 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KIR clearance
Top KIR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Proteins Intl., Inc. | 51 | 1993-03-24 |
| Viromed Laboratories, Inc. | 22 | 1996-05-22 |
| Advanced Clinical Diagnostics | 18 | 1994-02-03 |
| Earl-Clay Laboratories, Inc. | 17 | 1986-05-13 |
| Neogenex | 15 | 1997-02-04 |
13 more applicants have KIR clearances. See the full list in Caduvo.
Most recent KIR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K973209 | Diagnostic Hybrids, Inc. | FRESH CELLS VERO | 1997-09-25 | 29 |
| K973214 | Diagnostic Hybrids, Inc. | FRESH CELLS HFF | 1997-09-25 | 29 |
| K973212 | Diagnostic Hybrids, Inc. | FRESH CELLS WI-38 | 1997-09-25 | 29 |
| K973210 | Diagnostic Hybrids, Inc. | FRESH CELLS NCI H292 | 1997-09-25 | 29 |
| K973213 | Diagnostic Hybrids, Inc. | FRESH CELLS LLC-MK2 | 1997-09-25 | 29 |
Recalls for KIR devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2009-01-21.
Frequently asked questions
What is FDA product code KIR?
KIR is the FDA product code for cells, animal and human, cultured. It is a Class I device, regulated under 21 CFR 864.2280 and reviewed by the Pathology panel.
What device class is KIR?
Class I, regulation 21 CFR 864.2280. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KIR?
Across 170 cleared submissions the average was 75 days from receipt to decision (median 56).
Which companies have the most KIR clearances?
Proteins Intl., Inc. (51); Viromed Laboratories, Inc. (22); Advanced Clinical Diagnostics (18); Earl-Clay Laboratories, Inc. (17); Neogenex (15).
Have KIR devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2009-01-21.
Next steps
- Run an FDA pathway report with predicate devices for product code KIR
- Run a recall and safety report across every KIR manufacturer
- Watch product code KIR 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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