Microbiologics, Inc.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Microbiologics, Inc.” (first 1995, latest 2019), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 107 days. Since 2017 the median was 57 days, against 88 days for all cleared 510(k)s in the same product codes. 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 | 3 | 59 |
| 2019 | 5 | 55 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Microbiologics, Inc. took a median 57 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 88 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PMN | Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays | 8 | 8 |
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 7 | 7 |
| JSP | Kit, Anaerobic Identification | 3 | 3 |
Review panels
- Microbiology (18)
Most recent Microbiologics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K190086 | Cepheid Xpert Respiratory Control Panel | PMN | 2019-10-07 | 263 |
| K191168 | Cepheid Xpert SA Nasal Complete Control Panel | PMN | 2019-06-25 | 55 |
| K191172 | Cepheid Xpert MRSA NxG Control Panel | PMN | 2019-06-20 | 50 |
| K190223 | Cepheid Xpert CT/NG Control Panel | PMN | 2019-05-08 | 92 |
| K190463 | Cepheid Xpert C. difficile/Epi Control Panel | PMN | 2019-04-19 | 52 |
| K182472 | Cepheid Xpert GBS LB Control Panel | PMN | 2018-11-08 | 59 |
| K181683 | BD MAX CT/GC/TV 20-Day QC Panel | PMN | 2018-08-28 | 63 |
| K181711 | BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel | PMN | 2018-08-15 | 48 |
| K970009 | LYFO(TM) DIFFERENTIAL DISK-BACITRACIN | JTO | 1997-02-06 | 35 |
| K954812 | LYFO(TM) DIFFERIENTAL DISK-PYR | JTO | 1995-12-20 | 62 |
8 earlier clearances. See the full list in Caduvo.
Recalls
67 product recalls in 44 recall events; 23 initiated in the last five years. Most recent: 2025-12-02.
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 Microbiologics, Inc.?
FDA lists 18 510(k) clearances under the applicant name “Microbiologics, Inc.” (first 1995, latest 2019), across 3 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 Microbiologics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Microbiologics, Inc. is 107 days. Since 2017: 57 days, versus 88 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Microbiologics, Inc.?
The most frequent FDA product codes under this applicant name are PMN (Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays, 8); JTO (Discs, Strips And Reagents, Microorganism Differentiation, 7); JSP (Kit, Anaerobic Identification, 3).
Next steps
- See all 18 Microbiologics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code PMN, Microbiologics, Inc.'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.