Miltex, Inc.: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Miltex, Inc.” (first 1982, latest 2010), across 18 product codes in 5 review panels. Median 510(k) review time under this name: 16 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Integra LifeSciences, based on public ownership records.
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 |
|---|---|---|---|
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 5 | 5 |
| EKS | File, Pulp Canal, Endodontic | 2 | 2 |
| DZL | Screw, Fixation, Intraosseous | 1 | 1 |
| EIX | Probe, Periodontic | 1 | 1 |
| EIY | Instrument, Filling, Plastic, Dental | 1 | 1 |
| EJI | Syringe, Cartridge | 1 | 1 |
| EJL | Bur, Dental | 1 | 1 |
| EJZ | Knife, Margin Finishing, Operative | 1 | 1 |
| EKG | Condenser, Amalgam And Foil, Operative | 1 | 1 |
| EKH | Carver, Dental Amalgam, Operative | 1 | 1 |
Plus 8 more product codes.
Review panels
- Dental (14)
- General Hospital (5)
- Obstetrics and Gynecology (1)
- Orthopedic (1)
- General and Plastic Surgery (1)
Most recent Miltex, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K101653 | MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTES | KCT | 2010-08-02 | 52 |
| K092855 | MILTEX MEMBRANE TACK KIT | DZL | 2009-12-29 | 104 |
| K083796 | MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT | EJI | 2009-03-09 | 77 |
| K072563 | MILTEX RIGID CONTAINER SYSTEMS | KCT | 2008-02-12 | 154 |
| K061033 | MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS) | KCT | 2006-12-12 | 242 |
| K052018 | MILTEX LIGATING CLIP | FZP | 2005-11-04 | 101 |
| K050570 | MILTEX RIGID STERILIZATION CONTAINER SYSTEM | KCT | 2005-07-25 | 143 |
| K043013 | MILTEX LAPAROSCOPIC INSTRUMENTS | HET | 2005-03-04 | 122 |
| K013888 | FIXATION (STEINMANN) PINS | HTY | 2002-05-01 | 159 |
| K954185 | RE-BAG MULTI-USE POUCH, LARGE & SMALL | KCT | 1995-12-04 | 89 |
13 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2008-11-17.
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.
- Miltex Instrument Co. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Miltex, Inc.?
FDA lists 23 510(k) clearances under the applicant name “Miltex, Inc.” (first 1982, latest 2010), across 18 product codes in 5 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 Miltex, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Miltex, Inc. is 16 days.
Which FDA product codes appear under Miltex, Inc.?
The most frequent FDA product codes under this applicant name are KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, 5); EKS (File, Pulp Canal, Endodontic, 2); DZL (Screw, Fixation, Intraosseous, 1).
Next steps
- See all 23 Miltex, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KCT, Miltex, 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.