Instrumed International, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Instrumed International, Inc.” (first 2004, latest 2010), across 7 product codes in 4 review panels. Median 510(k) review time under this name: 65 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 |
|---|---|---|---|
| DWP | Dilator, Vessel, Surgical | 1 | 1 |
| DXC | Clamp, Vascular | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| GZT | Retractor, Self-Retaining, For Neurosurgery | 1 | 1 |
| HAE | Rongeur, Manual | 1 | 1 |
| HCZ | Forceps, Surgical, Gynecological | 1 | 1 |
| HDA | Forceps, Obstetrical | 1 | 1 |
Review panels
Most recent Instrumed International, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K100518 | INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 | DWP | 2010-08-31 | 189 |
| K100517 | INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX | HDA | 2010-04-29 | 65 |
| K092840 | INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL | HCZ | 2009-12-03 | 79 |
| K092544 | INSTRUMED VASCULAR CLAMPS | DXC | 2009-10-26 | 68 |
| K081651 | INSTRUMED RONGEUR | HAE | 2008-08-08 | 57 |
| K071771 | INSTRUMED RETRACTORS | GZT | 2007-08-02 | 34 |
| K040855 | INSTRUMED LAPAROSCOPE AND ACCESSORIES | GEI | 2004-04-16 | 14 |
Recalls
38 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2014-09-08.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Instrumed, Inc. (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Instrumed International, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Instrumed International, Inc.” (first 2004, latest 2010), across 7 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Instrumed International, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Instrumed International, Inc. is 65 days.
Which FDA product codes appear under Instrumed International, Inc.?
The most frequent FDA product codes under this applicant name are DWP (Dilator, Vessel, Surgical, 1); DXC (Clamp, Vascular, 1); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 1).
Next steps
- See all 7 Instrumed International, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DWP, Instrumed International, 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.