FDA product code JTQ: Bath, Incubators/Water, All
JTQ is the FDA product code for bath, incubators/water, all. It is a Class I device, regulated under 21 CFR 866.2540 and reviewed by the Microbiology panel. FDA has cleared 12 510(k) submissions under JTQ, from 10 different applicants. The average 510(k) review took 37 days (median 34). FDA has posted 11 recalls for JTQ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Bath, Incubators/Water, All |
| Device class | Class I |
| Regulation | 21 CFR 866.2540 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every JTQ clearance
Top JTQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Boekel Industries, Inc. | 2 | 1983-06-16 |
| Bionetic Laboratory Products | 2 | 1983-03-10 |
| Sterling Drug, Inc. | 1 | 1988-01-27 |
| Scientific Sales Intl., Inc. | 1 | 1985-09-03 |
| Remel Co. | 1 | 1983-03-28 |
5 more applicants have JTQ clearances. See the full list in Caduvo.
Most recent JTQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K875275 | Sterling Drug, Inc. | WINTHROP PHARMACEUTICALS CONTRAST MEDIA WARMER | 1988-01-27 | 34 |
| K853379 | Scientific Sales Intl., Inc. | PLATE INCUBATOR | 1985-09-03 | 22 |
| K831592 | Boekel Industries, Inc. | ANHYDRIC INCUBATORS, CULTURE INCUBATOR | 1983-06-16 | 30 |
| K830322 | Remel Co. | C.A.T. REAGENT KIT | 1983-03-28 | 56 |
| K830227 | Bionetic Laboratory Products | AUTOMATED ELISA READER LBI 300 | 1983-03-10 | 45 |
Recalls for JTQ devices
11 product recalls in 3 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2026-02-06.
| Year | Recalls |
|---|---|
| 2019 | 9 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code JTQ?
JTQ is the FDA product code for bath, incubators/water, all. It is a Class I device, regulated under 21 CFR 866.2540 and reviewed by the Microbiology panel.
What device class is JTQ?
Class I, regulation 21 CFR 866.2540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JTQ?
Across 12 cleared submissions the average was 37 days from receipt to decision (median 34).
Which companies have the most JTQ clearances?
Boekel Industries, Inc. (2); Bionetic Laboratory Products (2); Sterling Drug, Inc. (1); Scientific Sales Intl., Inc. (1); Remel Co. (1).
Have JTQ devices been recalled?
Yes: 11 product recalls across 3 recall events; the most recent began 2026-02-06.
Next steps
- Run an FDA pathway report with predicate devices for product code JTQ
- Run a recall and safety report across every JTQ manufacturer
- Watch product code JTQ 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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