Microbio-Medics, Inc.: FDA clearances and approvals
Microbio-Medics, Inc. has 13 FDA 510(k) clearances (first 1988, latest 1993), across 11 product codes in 5 review panels. Median 510(k) review time: 88 days.
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 |
|---|---|---|---|
| ETA | Replacement, Ossicular Prosthesis, Total | 3 | 3 |
| EPP | Splint, Nasal | 1 | 1 |
| ETB | Prosthesis, Partial Ossicular Replacement | 1 | 1 |
| ETD | Tube, Tympanostomy | 1 | 1 |
| EWO | Audiometer | 1 | 1 |
| FTA | Light, Surgical, Accessories | 1 | 1 |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | 1 | 1 |
| HAO | Instrument, Surgical, Non-Powered | 1 | 1 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 1 | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 | 1 |
Plus 1 more product codes.
Review panels
- Ear, Nose and Throat (8)
- General and Plastic Surgery (2)
- Clinical Chemistry (1)
- General Hospital (1)
- Neurology (1)
Most recent Microbio-Medics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K923353 | VENTILATION TUBES W/ HYDROGEL COATING | ETD | 1993-05-18 | 314 |
| K922572 | 321Q MINIMUM ENERGY TINNITUS SUPPRESSOR | KLW | 1992-11-02 | 154 |
| K913276 | MICROTEK MEDICAL'S SOUND STIKS | EWO | 1991-10-21 | 90 |
| K904239 | SOFT HYDROXYLAPATITE OSSICULAR MALLEABLE PROSTHES | ETA | 1991-06-21 | 281 |
| K910167 | MICROTEK-HERITAGES SILICONE BULB EVACUATION SYSTEM | GCY | 1991-04-15 | 90 |
| K900726 | MICROTEK MEDICAL'S BLOOD COLLECTION KIT | JKA | 1990-05-04 | 78 |
| K901154 | MICROTEK'S SURGICAL LAMP HANDLE & COVER | FTA | 1990-03-20 | 7 |
| K895815 | MICROTEK TOTAL OSSICULAR PROTHESIS | ETA | 1989-12-26 | 88 |
| K895814 | MICROTEK PISTON & WIRE PROSTHESES | ETB | 1989-12-26 | 88 |
| K895502 | MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT | EPP | 1989-12-08 | 87 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Microbio-Medics, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Microbio-Medics, Inc. have?
Microbio-Medics, Inc. has 13 FDA 510(k) clearances (first 1988, latest 1993), across 11 product codes in 5 review panels.
How long does FDA take to clear Microbio-Medics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Microbio-Medics, Inc.'s cleared 510(k)s is 88 days.
What devices does Microbio-Medics, Inc. make?
Its most frequent FDA product codes are ETA (Replacement, Ossicular Prosthesis, Total, 3); EPP (Splint, Nasal, 1); ETB (Prosthesis, Partial Ossicular Replacement, 1).
Has Microbio-Medics, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Microbio-Medics, Inc. Related entities may recall under other names.
Next steps
- See all 13 Microbio-Medics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ETA, Microbio-Medics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.