Katalyst Surgical, LLC: FDA clearances and approvals
Katalyst Surgical, LLC has 7 FDA 510(k) clearances (first 2012, latest 2022), across 5 product codes in 2 review panels. Median 510(k) review time: 215 days. Since 2017 its median was 240 days, against 112 days for all cleared 510(k)s in the same product codes. openFDA lists 12 product recalls by a recalling firm named Katalyst Surgical, LLC.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 112 |
| 2013 | 0 | — |
| 2014 | 1 | 215 |
| 2015 | 1 | 281 |
| 2016 | 0 | — |
| 2017 | 1 | 175 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 240 |
| 2021 | 0 | — |
| 2022 | 1 | 326 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Katalyst Surgical, LLC's cleared 510(k)s took a median 240 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 2 |
| HQF | Laser, Ophthalmic | 2 | 2 |
| HBI | Illuminator, Fiberoptic, Surgical Field | 1 | 1 |
| LFL | Instrument, Ultrasonic Surgical | 1 | 1 |
| LQJ | Lens, Surgical, Laser, Accesssory, Ophthalmic Laser | 1 | 1 |
Review panels
Most recent Katalyst Surgical, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K213610 | Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps | GEI | 2022-10-07 | 326 |
| K192963 | Kogent Torus Ultrasonic Aspirator | LFL | 2020-06-19 | 240 |
| K163632 | Katalyst Cyclophotocoagulation Probe | LQJ | 2017-06-15 | 175 |
| K141781 | KOGENT SPETZLER LIGHTED SUCTION TUBES | HBI | 2015-04-09 | 281 |
| K140362 | KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES, KATALYST REVOLVER ILLUMINATED PROBES | HQF | 2014-09-15 | 215 |
| K123172 | KOGENT BIPOLAR FORCEPS | GEI | 2012-12-21 | 73 |
| K121187 | KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES | HQF | 2012-09-17 | 151 |
Recalls
12 product recalls in 1 recall events; 12 initiated in the last five years. Most recent: 2026-03-25.
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 Katalyst Surgical, LLC have?
Katalyst Surgical, LLC has 7 FDA 510(k) clearances (first 2012, latest 2022), across 5 product codes in 2 review panels.
How long does FDA take to clear Katalyst Surgical, LLC's 510(k)s?
The median time from FDA receipt to decision across Katalyst Surgical, LLC's cleared 510(k)s is 215 days. Since 2017: 240 days, versus 112 days for all cleared 510(k)s in the same product codes.
What devices does Katalyst Surgical, LLC make?
Its most frequent FDA product codes are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 2); HQF (Laser, Ophthalmic, 2); HBI (Illuminator, Fiberoptic, Surgical Field, 1).
Has Katalyst Surgical, LLC had device recalls?
openFDA lists 12 product recalls in 1 recall event by a recalling firm whose name matches Katalyst Surgical, LLC; the most recent began 2026-03-25. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 7 Katalyst Surgical, LLC clearances with predicates and recalls
- Run predicate analysis for product code GEI, Katalyst Surgical, LLC'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.