Medspec Corp.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Medspec Corp.” (first 1980, latest 1981), across 11 product codes in 4 review panels. Median 510(k) review time under this name: 36 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 |
|---|---|---|---|
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | 4 | 4 |
| KKX | Drape, Surgical, Antimicrobial | 2 | 2 |
| CAE | Airway, Oropharyngeal, Anesthesiology | 1 | 1 |
| EFN | Cotton, Roll | 1 | 1 |
| FQM | Bandage, Elastic | 1 | 1 |
| FRL | Fiber, Medical, Absorbent | 1 | 1 |
| FYC | Gown, Isolation, Surgical | 1 | 1 |
| GBS | Catheter, Ventricular, General & Plastic Surgery | 1 | 1 |
| LDQ | 1 | 1 | |
| NAB | Gauze / Sponge,Nonresorbable For External Use | 1 | 1 |
Plus 1 more product codes.
Review panels
- General and Plastic Surgery (6)
- General Hospital (5)
- Anesthesiology (1)
- Dental (1)
Most recent Medspec Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K813012 | STERILE BASIN SETS | LDQ | 1981-11-06 | 10 |
| K812711 | STERILE GAUZE PADS 12PLY | NAB | 1981-11-02 | 39 |
| K812710 | STERILE LAPAROTOMY SPONGES-X-RAY DETECT | GDY | 1981-11-02 | 39 |
| K812707 | STERILE DISSECTOR SPONGES-X-RAY DETECT | GDY | 1981-11-02 | 39 |
| K812709 | STERILE DENTAL ROLL | EFN | 1981-10-23 | 29 |
| K810071 | STERILE SILICONE TUBING | GBS | 1981-02-12 | 30 |
| K810069 | STERILE AIRWAY | CAE | 1981-02-02 | 20 |
| K802060 | STERILE TONSIL SPONGES | GDY | 1980-10-10 | 46 |
| K801069 | STERILE ISOLATION GOWN | FYC | 1980-05-20 | 14 |
| K801068 | STERILE ABDOMINAL PAD | KKX | 1980-05-20 | 14 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medspec Corp..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Medspec Corp.?
FDA lists 15 510(k) clearances under the applicant name “Medspec Corp.” (first 1980, latest 1981), across 11 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 Medspec Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medspec Corp. is 36 days.
Which FDA product codes appear under Medspec Corp.?
The most frequent FDA product codes under this applicant name are GDY (Gauze/Sponge, Internal, X-Ray Detectable, 4); KKX (Drape, Surgical, Antimicrobial, 2); CAE (Airway, Oropharyngeal, Anesthesiology, 1).
Next steps
- See all 15 Medspec Corp. clearances with predicates and recalls
- Run predicate analysis for product code GDY, Medspec Corp.'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.