Medi-Spec: FDA clearances and approvals
Medi-Spec has 8 FDA 510(k) clearances (first 1978, latest 1984), across 7 product codes in 4 review panels. Median 510(k) review time: 39 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 |
|---|---|---|---|
| KKX | Drape, Surgical, Antimicrobial | 2 | 2 |
| GAD | Retractor | 1 | 1 |
| GEE | Brush, Biopsy, General & Plastic Surgery | 1 | 1 |
| HDY | Dilator, Cervical, Hygroscopic-Laminaria | 1 | 1 |
| HHK | Curette, Suction, Endometrial (And Accessories) | 1 | 1 |
| HIX | Maxwell Spot, Ac-Powered | 1 | 1 |
| HMP | Pad, Eye | 1 | 1 |
Review panels
Most recent Medi-Spec 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K833068 | LAMINARIA JAPONICA CERVICAL DILATOR | HDY | 1984-02-04 | 149 |
| K812694 | WHISK-R | GEE | 1981-10-26 | 34 |
| K812426 | UTERINE ASPIRATION CURETTES(RIGID&FLEX) | HHK | 1981-10-08 | 44 |
| K801554 | STERILE CAST PADDING | HIX | 1980-08-04 | 27 |
| K800404 | MEDSPEC OPERATIVE OPTHALMIC KIT | HMP | 1980-04-24 | 58 |
| K800490 | STERILE DRESSING PACK | KKX | 1980-03-12 | 8 |
| K790952 | CLAMP COVERS | GAD | 1979-06-05 | 14 |
| K780548 | DISPOSA-LOOPS | KKX | 1978-08-21 | 138 |
Recalls
openFDA lists no recalls under a recalling firm named Medi-Spec.
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 Medi-Spec have?
Medi-Spec has 8 FDA 510(k) clearances (first 1978, latest 1984), across 7 product codes in 4 review panels.
How long does FDA take to clear Medi-Spec's 510(k)s?
The median time from FDA receipt to decision across Medi-Spec's cleared 510(k)s is 39 days.
What devices does Medi-Spec make?
Its most frequent FDA product codes are KKX (Drape, Surgical, Antimicrobial, 2); GAD (Retractor, 1); GEE (Brush, Biopsy, General & Plastic Surgery, 1).
Has Medi-Spec had device recalls?
openFDA lists no recalls under a recalling firm name matching Medi-Spec. Related entities may recall under other names.
Next steps
- See all 8 Medi-Spec clearances with predicates and recalls
- Run predicate analysis for product code KKX, Medi-Spec'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.