Medtech Products, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Medtech Products, Inc.” (first 1985, latest 2024), across 7 product codes in 6 review panels. Median 510(k) review time under this name: 133 days. Since 2017 the median was 87 days, against 116 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 | 1 | 129 |
| 2017 | 2 | 96 |
| 2018 | 1 | 160 |
| 2019 | 0 | — |
| 2020 | 1 | 83 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 50 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Medtech Products, Inc. took a median 87 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 116 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HIS | Condom | 4 | 4 |
| GEH | Unit, Cryosurgical, Accessories | 3 | 3 |
| KHE | Reagent, Occult Blood | 2 | 2 |
| OBR | Mouthguard, Over-The-Counter | 2 | 2 |
| KXZ | System, Thermographic, Liquid Crystal, Powered (Adjunctive Use) | 1 | 1 |
| LJL | Detectors And Removers, Lice, (Including Combs) | 1 | 1 |
| LTZ | Condom With Nonoxynol-9 | 1 | 1 |
Review panels
- Obstetrics and Gynecology (5)
- General and Plastic Surgery (3)
- Dental (2)
- Hematology (2)
- General Hospital (1)
- Radiology (1)
Most recent Medtech Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242803 | Compound W Skin Tag Remover | GEH | 2024-11-06 | 50 |
| K202974 | DenTek Fresh Protect Dental Guard | OBR | 2020-12-22 | 83 |
| K180933 | DenTek Ultimate Dental Guard | OBR | 2018-09-17 | 160 |
| K172373 | Compound W Nitro-Freeze | GEH | 2017-11-02 | 87 |
| K163401 | Nix Ultra Lice Treatment Kit | LJL | 2017-03-21 | 106 |
| K161294 | Compound W Wart Removal System Dual Power | GEH | 2016-09-15 | 129 |
| K063401 | BANANA RIBBED | HIS | 2007-03-26 | 137 |
| K012969 | DOUBLE SPRINGERS NONOXNOL 9 CONDOM | LTZ | 2002-06-12 | 281 |
| K993737 | MIGHTY MAN (DYNAMIC LINKERS) | HIS | 2000-03-20 | 137 |
| K993735 | DOUBLE SPRINGERS | HIS | 2000-03-20 | 137 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medtech Products, Inc..
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.
- Medtech S.A (8 510(k)s)
- Medtech Intl., Inc. (6 510(k)s)
- Medtech Industries, Inc. (4 510(k)s)
- Medtech S.A.S (3 510(k)s)
- Medtech Instruments (2 510(k)s)
- Medtech , Ltd. (1 510(k)s)
- Medtech Systems, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medtech Products, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Medtech Products, Inc.” (first 1985, latest 2024), across 7 product codes in 6 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 Medtech Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medtech Products, Inc. is 133 days. Since 2017: 87 days, versus 116 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Medtech Products, Inc.?
The most frequent FDA product codes under this applicant name are HIS (Condom, 4); GEH (Unit, Cryosurgical, Accessories, 3); KHE (Reagent, Occult Blood, 2).
Next steps
- See all 14 Medtech Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HIS, Medtech Products, 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.