Tecnol Medical Products, Inc.: FDA clearances and approvals
Tecnol Medical Products, Inc. has 21 FDA 510(k) clearances (first 1992, latest 1997), across 7 product codes in 2 review panels. Median 510(k) review time: 78 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 |
|---|---|---|---|
| FMQ | Restraint, Protective | 9 | 9 |
| FXX | Mask, Surgical | 5 | 5 |
| MGP | Dressing, Wound And Burn, Occlusive | 2 | 2 |
| MSH | Respirator, Surgical | 2 | 2 |
| FRO | Dressing, Wound, Drug | 1 | 1 |
| LYU | Accessory, Surgical Apparel | 1 | 1 |
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | 1 | 1 |
Review panels
Most recent Tecnol Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K974068 | PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL | MSH | 1997-12-22 | 55 |
| K970448 | PCM 2000; ISOLAIR APR MODEL 2735 | MSH | 1997-04-30 | 83 |
| K963564 | PERSONAL LIMB HOLDER (24444-200,300,24444-KIT) | FMQ | 1996-11-22 | 78 |
| K963559 | WRPAROUND LIMB HOLDER (24446,24446-350,24447-010,24449-010) | FMQ | 1996-11-22 | 78 |
| K963552 | QUICK RELEASE LIMB HOLDER (24442,24442-050,24442-350) | FMQ | 1996-11-22 | 78 |
| K963773 | 24457-010 SECURE ALL PELVIC HOLDER/24458-010 SECURE ALL BODY BELT | FMQ | 1996-11-21 | 63 |
| K963563 | ULTRACARE VEST STYLE BODY HOLDER WITH SAFETY SLEEVES, SMALL(24454-010,020,030,040,015,025,035,045,115,125,135,145) | FMQ | 1996-11-21 | 77 |
| K963561 | ULTRA CARE VEST STYLE BODY HOLDER, SMALL (24455-010,020,030,040,24456-010,020,030,040) | FMQ | 1996-11-21 | 77 |
| K963557 | SYSTEM 2 ZIPPERED BODY HOLDER, SMALL/MEDIUM 24453-010,24453-020,24453-030 | FMQ | 1996-11-21 | 77 |
| K963556 | SECURE-ALL 1-PIECE BODY HOLDER, SMALL/MEDIUM (24451-010,020,24452-010,020,030) | FMQ | 1996-11-21 | 77 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Tecnol Medical Products, 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 Tecnol Medical Products, Inc. have?
Tecnol Medical Products, Inc. has 21 FDA 510(k) clearances (first 1992, latest 1997), across 7 product codes in 2 review panels.
How long does FDA take to clear Tecnol Medical Products, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Tecnol Medical Products, Inc.'s cleared 510(k)s is 78 days.
What devices does Tecnol Medical Products, Inc. make?
Its most frequent FDA product codes are FMQ (Restraint, Protective, 9); FXX (Mask, Surgical, 5); MGP (Dressing, Wound And Burn, Occlusive, 2).
Has Tecnol Medical Products, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Tecnol Medical Products, Inc. Related entities may recall under other names.
Next steps
- See all 21 Tecnol Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FMQ, Tecnol Medical Products, 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.