FDA product code JWY: Manual Antimicrobial Susceptibility Test Systems
JWY is the FDA product code for manual antimicrobial susceptibility test systems. It is a Class II device, regulated under 21 CFR 866.1640 and reviewed by the Microbiology panel. FDA has cleared 441 510(k) submissions under JWY, 29 in the last five years, from 48 different applicants. The average 510(k) review took 89 days (median 69); 94 days on average over the last three years. 1 PMA application cites this product code. FDA has posted 78 recalls for JWY devices, 32 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Manual Antimicrobial Susceptibility Test Systems |
| Device class | Class II |
| Regulation | 21 CFR 866.1640 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for JWY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 14 | 64 |
| 2018 | 12 | 51 |
| 2019 | 18 | 62 |
| 2020 | 5 | 67 |
| 2021 | 5 | 266 |
| 2023 | 7 | 74 |
| 2024 | 6 | 88 |
| 2025 | 14 | 138 |
| 2026 | 2 | 57 |
Compare with all 510(k) review times · Search every JWY clearance
Top JWY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ab Biodisk | 61 | 2008-07-24 |
| Thermo Fisher Scientific | 47 | 2025-09-25 |
| Trek Diagnostic Systems, Inc. | 44 | 2010-02-17 |
| Pasco Laboratories, Inc. | 39 | 2004-10-07 |
| Liofilchem s.r.l. | 35 | 2026-04-17 |
43 more applicants have JWY clearances. See the full list in Caduvo.
Most recent JWY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260447 | bioMérieux SA | ETEST Gepotidacin (GEP) (0.016-256 µg/mL) | 2026-04-21 | 69 |
| K260696 | Liofilchem s.r.l. | MTS Gepotidacin 0.016-256 µg/mL | 2026-04-17 | 45 |
| K252114 | Liofilchem s.r.l. | MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL | 2025-10-02 | 87 |
| K252062 | Thermo Fisher Scientific | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL | 2025-09-25 | 86 |
| K250575 | Thermo Fisher Scientific | The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL | 2025-09-05 | 191 |
Recalls for JWY devices
78 product recalls in 22 recall events; 32 initiated in the last five years and 23 still open. Most recent: 2025-05-01.
| Year | Recalls |
|---|---|
| 2017 | 5 |
| 2018 | 1 |
| 2021 | 1 |
| 2022 | 31 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code JWY?
JWY is the FDA product code for manual antimicrobial susceptibility test systems. It is a Class II device, regulated under 21 CFR 866.1640 and reviewed by the Microbiology panel.
What device class is JWY?
Class II, regulation 21 CFR 866.1640. Typical premarket route: 510(k).
How long does a 510(k) take for product code JWY?
Across 441 cleared submissions the average was 89 days from receipt to decision (median 69).
Which companies have the most JWY clearances?
Ab Biodisk (61); Thermo Fisher Scientific (47); Trek Diagnostic Systems, Inc. (44); Pasco Laboratories, Inc. (39); Liofilchem s.r.l. (35).
Have JWY devices been recalled?
Yes: 78 product recalls across 22 recall events; the most recent began 2025-05-01.
Next steps
- Run an FDA pathway report with predicate devices for product code JWY
- Run a recall and safety report across every JWY manufacturer
- Watch product code JWY 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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