FDA product code KJA: Flask, Tissue Culture
KJA is the FDA product code for flask, tissue culture. It is a Class I device, regulated under 21 CFR 864.2240 and reviewed by the Pathology panel. FDA has cleared 13 510(k) submissions under KJA, from 9 different applicants. The average 510(k) review took 48 days (median 26). FDA has posted 1 recall for KJA devices.
Classification
| Field | Value |
|---|---|
| Device name | Flask, Tissue Culture |
| Device class | Class I |
| Regulation | 21 CFR 864.2240 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every KJA clearance
Top KJA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 2 | 1997-07-22 |
| American Fluoroseal Corp. | 2 | 1994-03-30 |
| Nunc, Inc. | 2 | 1987-11-25 |
| Travenol Laboratories, S.A. | 2 | 1986-06-16 |
| E.I. Dupont DE Nemours & Co., Inc. | 1 | 1987-04-14 |
4 more applicants have KJA clearances. See the full list in Caduvo.
Most recent KJA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K972404 | Bd Becton Dickinson Vacutainer Systems Preanalytic | VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE) | 1997-07-22 | 26 |
| K933228 | American Fluoroseal Corp. | KAPTON PEEL POUCH | 1994-03-30 | 271 |
| K885121 | Bd Becton Dickinson Vacutainer Systems Preanalytic | CELL SCRAPER | 1988-12-28 | 16 |
| K873889 | Nunc, Inc. | TISSUE CULTURE TUBES | 1987-11-25 | 63 |
| K873890 | Nunc, Inc. | TISSUE CULTURE FLASKS | 1987-11-25 | 63 |
Recalls for KJA devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-01-28.
| Year | Recalls |
|---|---|
| 2021 | 1 |
Frequently asked questions
What is FDA product code KJA?
KJA is the FDA product code for flask, tissue culture. It is a Class I device, regulated under 21 CFR 864.2240 and reviewed by the Pathology panel.
What device class is KJA?
Class I, regulation 21 CFR 864.2240. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KJA?
Across 13 cleared submissions the average was 48 days from receipt to decision (median 26).
Which companies have the most KJA clearances?
Bd Becton Dickinson Vacutainer Systems Preanalytic (2); American Fluoroseal Corp. (2); Nunc, Inc. (2); Travenol Laboratories, S.A. (2); E.I. Dupont DE Nemours & Co., Inc. (1).
Have KJA devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2021-01-28.
Next steps
- Run an FDA pathway report with predicate devices for product code KJA
- Run a recall and safety report across every KJA manufacturer
- Watch product code KJA 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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