Anaerobe Systems: FDA filings under this applicant name
FDA lists 52 510(k) clearances under the applicant name “Anaerobe Systems” (first 1978, latest 1985), across 10 product codes in 1 review panel. Median 510(k) review time under this name: 24 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JSI | Culture Media, Selective And Differential | 12 | 12 |
| JSG | Culture Media, Non-Selective And Non-Differential | 8 | 8 |
| JSJ | Culture Media, Selective And Non-Differential | 8 | 8 |
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 8 | 8 |
| JSC | Culture Media, General Nutrient Broth | 6 | 6 |
| JSH | Culture Media, Non-Selective And Differential | 3 | 3 |
| JSE | Culture Media, Multiple Biochemical Test | 2 | 2 |
| JSL | Culture Media, Anaerobic Transport | 2 | 2 |
| JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | 2 | 2 |
| JSF | Culture Media, Single Biochemical Test | 1 | 1 |
Review panels
- Microbiology (52)
Most recent Anaerobe Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K844383 | KANAMYCIN 1000 MCG DIFFERENTIAL DISK | JTO | 1985-01-04 | 52 |
| K844382 | VANCOMYCIN 5MCG DIFFERENTIAL DISK | JTO | 1985-01-04 | 52 |
| K844381 | COLISTIN 10 MCG. DIFFERENTIAL DISK | JTO | 1985-01-04 | 52 |
| K844380 | BILE DIFFERENTIAL DISK | JTO | 1985-01-04 | 52 |
| K841303 | CAMPYLOBACTER THIOGLYCOLLATE MED | JSG | 1984-04-17 | 18 |
| K841218 | CYCLOSERINE-CEFOXITIN FRUCTOSE AGAR | JSI | 1984-04-05 | 14 |
| K841142 | LEVINE EOSIN METHYLENE BLUE AGAR | JSI | 1984-04-05 | 20 |
| K841222 | BACTEROIDES BILE ESCULIN GAR | JSI | 1984-04-04 | 13 |
| K841221 | BRAIN HEART INFUSION BROTH | JSC | 1984-04-04 | 13 |
| K841220 | ANAEROBIC TRANSPORT MEDIUM | JSL | 1984-04-04 | 13 |
42 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Anaerobe Systems.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Anaerobe Systems?
FDA lists 52 510(k) clearances under the applicant name “Anaerobe Systems” (first 1978, latest 1985), across 10 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Anaerobe Systems?
The median time from FDA receipt to decision across 510(k)s cleared under the name Anaerobe Systems is 24 days.
Which FDA product codes appear under Anaerobe Systems?
The most frequent FDA product codes under this applicant name are JSI (Culture Media, Selective And Differential, 12); JSG (Culture Media, Non-Selective And Non-Differential, 8); JSJ (Culture Media, Selective And Non-Differential, 8).
Next steps
- See all 52 Anaerobe Systems clearances with predicates and recalls
- Run predicate analysis for product code JSI, Anaerobe Systems's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.