Surgikos, Inc.: FDA clearances and approvals
Surgikos, Inc. has 56 FDA 510(k) clearances (first 1976, latest 1988), across 17 product codes in 6 review panels. Median 510(k) review time: 28 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 | 30 | 30 |
| FYA | Gown, Surgical | 5 | 5 |
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | 2 | 2 |
| FXX | Mask, Surgical | 2 | 2 |
| FXY | Hood, Surgical | 2 | 2 |
| KGO | Surgeon'S Gloves | 2 | 2 |
| BZQ | Monitor, Breathing Frequency | 1 | 1 |
| CAK | Microfilter, Blood Transfusion | 1 | 1 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 1 | 1 |
| FKQ | System, Dialysate Delivery, Central Multiple Patient | 1 | 1 |
Plus 7 more product codes.
Review panels
- General Hospital (43)
- Cardiovascular (4)
- General and Plastic Surgery (3)
- Anesthesiology (1)
- Gastroenterology and Urology (1)
- Ophthalmic (1)
Most recent Surgikos, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K875107 | HEALTH CARE EYE PROTECTION | HOY | 1988-03-21 | 98 |
| K874653 | STERILE SURGICAL SCRUB BRUSH | GEC | 1987-12-30 | 47 |
| K861441 | NEUTRALON SURGICAL GLOVES | KGO | 1986-05-30 | 43 |
| K852870 | BARRIER SURGICAL GOWN | FYA | 1985-07-23 | 15 |
| K822535 | CIDEX*DIALYZER DISINFECTING SOLUTION | FKQ | 1982-09-30 | 37 |
| K820543 | BARRIER ANTIMICROBIAL INCISE DRAPE | KKX | 1982-07-22 | 142 |
| K820542 | SURGIKOS INCISE DRAPE | KKX | 1982-06-02 | 92 |
| K811871 | BACTERICIDAL INCISE DRAPE | KKX | 1981-08-20 | 50 |
| K810316 | SURGIKOS FACE MASK | FXX | 1981-02-23 | 17 |
| K801864 | BARRIER APERTURED DRAPE | KKX | 1980-08-20 | 15 |
46 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Surgikos, 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 Surgikos, Inc. have?
Surgikos, Inc. has 56 FDA 510(k) clearances (first 1976, latest 1988), across 17 product codes in 6 review panels.
How long does FDA take to clear Surgikos, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Surgikos, Inc.'s cleared 510(k)s is 28 days.
What devices does Surgikos, Inc. make?
Its most frequent FDA product codes are KKX (Drape, Surgical, Antimicrobial, 30); FYA (Gown, Surgical, 5); DTM (Filter, Blood, Cardiopulmonary Bypass, Arterial Line, 2).
Has Surgikos, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Surgikos, Inc. Related entities may recall under other names.
Next steps
- See all 56 Surgikos, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KKX, Surgikos, 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.