FDA product code KZJ: Device, Gas Generating
KZJ is the FDA product code for device, gas generating. It is a Class I device, regulated under 21 CFR 866.2580 and reviewed by the Microbiology panel. FDA has cleared 18 510(k) submissions under KZJ, from 8 different applicants. The average 510(k) review took 26 days (median 23). FDA has posted 4 recalls for KZJ devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Device, Gas Generating |
| Device class | Class I |
| Regulation | 21 CFR 866.2580 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KZJ clearance
Top KZJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 8 | 1987-08-06 |
| Fairleigh Dickinson Laboratories, Inc. | 2 | 1988-04-27 |
| Marion Laboratories, Inc. | 2 | 1986-06-16 |
| Oxoid U.S.A., Inc. | 2 | 1982-01-28 |
| Difco Laboratories, Inc. | 1 | 1987-05-15 |
3 more applicants have KZJ clearances. See the full list in Caduvo.
Most recent KZJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K881502 | Fairleigh Dickinson Laboratories, Inc. | BREWER GEL FOR CAMPYLOBACTER | 1988-04-27 | 16 |
| K875362 | Fairleigh Dickinson Laboratories, Inc. | BREWER GEL FOR ANAEROBES | 1988-01-27 | 27 |
| K872782 | Bd Becton Dickinson Vacutainer Systems Preanalytic | BBL(R) GASPAK CO2 POUCH(TM) | 1987-08-06 | 23 |
| K871709 | Difco Laboratories, Inc. | ANAEROBIC TRANSPORT POUCH (CATALYST-FREE) | 1987-05-15 | 14 |
| K871238 | Scott Laboratories, Inc. | ANABAG | 1987-04-03 | 7 |
Recalls for KZJ devices
4 product recalls in 3 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2026-04-07.
| Year | Recalls |
|---|---|
| 2026 | 2 |
Frequently asked questions
What is FDA product code KZJ?
KZJ is the FDA product code for device, gas generating. It is a Class I device, regulated under 21 CFR 866.2580 and reviewed by the Microbiology panel.
What device class is KZJ?
Class I, regulation 21 CFR 866.2580. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KZJ?
Across 18 cleared submissions the average was 26 days from receipt to decision (median 23).
Which companies have the most KZJ clearances?
Bd Becton Dickinson Vacutainer Systems Preanalytic (8); Fairleigh Dickinson Laboratories, Inc. (2); Marion Laboratories, Inc. (2); Oxoid U.S.A., Inc. (2); Difco Laboratories, Inc. (1).
Have KZJ devices been recalled?
Yes: 4 product recalls across 3 recall events; the most recent began 2026-04-07.
Next steps
- Run an FDA pathway report with predicate devices for product code KZJ
- Run a recall and safety report across every KZJ manufacturer
- Watch product code KZJ 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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