Calgon Vestal Div.: FDA clearances and approvals
Calgon Vestal Div. has 19 FDA 510(k) clearances (first 1989, latest 1994), across 6 product codes in 2 review panels. Median 510(k) review time: 86 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 |
|---|---|---|---|
| LRJ | Disinfectant, Medical Devices | 5 | 5 |
| FLG | Cleaner, Ultrasonic, Medical Instrument | 3 | 3 |
| FRO | Dressing, Wound, Drug | 3 | 3 |
| KMF | Bandage, Liquid | 3 | 3 |
| QSY | Hemostatic Wound Dressing Without Thrombin Or Other Biologics | 3 | 3 |
| MGP | Dressing, Wound And Burn, Occlusive | 2 | 2 |
Review panels
Most recent Calgon Vestal Div. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K944494 | ALSA-KLENZ | FLG | 1994-10-19 | 36 |
| K944033 | BILL EVANS-KLENZ | FLG | 1994-10-07 | 51 |
| K942270 | SAF-GEL HYDRATING DERMAL WOUND DRESSING | KMF | 1994-08-04 | 86 |
| K931477 | AMERSE | LRJ | 1994-06-17 | 450 |
| K931816 | VESTA-SYDE(R) INTERIM INSTR DECONTAMINATION SYSTEM | LRJ | 1994-05-26 | 413 |
| K931342 | LPH | LRJ | 1994-05-26 | 435 |
| K941163 | MON-KLENZ | FLG | 1994-05-18 | 68 |
| K931573 | VESPHENE II | LRJ | 1994-05-16 | 412 |
| K932277 | LONZA FORMULATION R-82 | LRJ | 1994-05-12 | 365 |
| K931599 | HYDRASORB STERILE DRESSING | MGP | 1993-07-08 | 98 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Calgon Vestal Div..
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 Calgon Vestal Div. have?
Calgon Vestal Div. has 19 FDA 510(k) clearances (first 1989, latest 1994), across 6 product codes in 2 review panels.
How long does FDA take to clear Calgon Vestal Div.'s 510(k)s?
The median time from FDA receipt to decision across Calgon Vestal Div.'s cleared 510(k)s is 86 days.
What devices does Calgon Vestal Div. make?
Its most frequent FDA product codes are LRJ (Disinfectant, Medical Devices, 5); FLG (Cleaner, Ultrasonic, Medical Instrument, 3); FRO (Dressing, Wound, Drug, 3).
Has Calgon Vestal Div. had device recalls?
openFDA lists no recalls under a recalling firm name matching Calgon Vestal Div. Related entities may recall under other names.
Next steps
- See all 19 Calgon Vestal Div. clearances with predicates and recalls
- Run predicate analysis for product code LRJ, Calgon Vestal Div.'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.