Micromed Development Corp.: FDA clearances and approvals
Micromed Development Corp. has 14 FDA 510(k) clearances (first 1994, latest 1996), across 7 product codes in 2 review panels. Median 510(k) review time: 35 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 |
|---|---|---|---|
| ETD | Tube, Tympanostomy | 5 | 5 |
| ETB | Prosthesis, Partial Ossicular Replacement | 4 | 4 |
| EPP | Splint, Nasal | 1 | 1 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | 1 | 1 |
| ETA | Replacement, Ossicular Prosthesis, Total | 1 | 1 |
| ETN | Stimulator, Nerve | 1 | 1 |
| LRO | General Surgery Tray | 1 | 1 |
Review panels
Most recent Micromed Development Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K945105 | POLY/PLATINUM WIRE PISTON | ETB | 1996-05-14 | 574 |
| K945831 | DISPOSABLE JOINT ASPIRATION/INJECTION DIAGNOSTIC KIT | LRO | 1995-01-20 | 52 |
| K945242 | NERVE MONITOR ELECTRODES/STIMULATOR PROBES | ETN | 1994-12-27 | 61 |
| K945438 | EDI-BUR MICRODRILL SYSTEMS | ERL | 1994-11-22 | 33 |
| K945108 | POLY PISTON | ETB | 1994-11-22 | 35 |
| K945107 | POLY-WIRE PISTON | ETB | 1994-11-22 | 35 |
| K945106 | MICROMED TOTAL REGULAR AND PARTIAL OFFSET | ETA | 1994-11-22 | 35 |
| K945104 | MICROMED PARTIAL REGULAR AND PARTIAL OFFSET | ETB | 1994-11-22 | 35 |
| K943848 | COLLAR BUTTON VENTURI VENT TUBE | ETD | 1994-09-16 | 43 |
| K943849 | GROMMENT STYLE VENTURI TUBE | ETD | 1994-09-02 | 29 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Micromed Development Corp..
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 Micromed Development Corp. have?
Micromed Development Corp. has 14 FDA 510(k) clearances (first 1994, latest 1996), across 7 product codes in 2 review panels.
How long does FDA take to clear Micromed Development Corp.'s 510(k)s?
The median time from FDA receipt to decision across Micromed Development Corp.'s cleared 510(k)s is 35 days.
What devices does Micromed Development Corp. make?
Its most frequent FDA product codes are ETD (Tube, Tympanostomy, 5); ETB (Prosthesis, Partial Ossicular Replacement, 4); EPP (Splint, Nasal, 1).
Has Micromed Development Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Micromed Development Corp. Related entities may recall under other names.
Next steps
- See all 14 Micromed Development Corp. clearances with predicates and recalls
- Run predicate analysis for product code ETD, Micromed Development Corp.'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.