Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Calgon Vestal Div. — Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
435 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K944494 | ALSA-KLENZ | Calgon Vestal Div. | 1994-10-19 | 36 | 0 |
| K944033 | BILL EVANS-KLENZ | Calgon Vestal Div. | 1994-10-07 | 51 | 0 |
| K942270 | SAF-GEL HYDRATING DERMAL WOUND DRESSING | Calgon Vestal Div. | 1994-08-04 | 86 | 0 |
| K931477 | AMERSE | Calgon Vestal Div. | 1994-06-17 | 450 | 0 |
| K931816 | VESTA-SYDE(R) INTERIM INSTR DECONTAMINATION SYSTEM | Calgon Vestal Div. | 1994-05-26 | 413 | 0 |
| K931342 | LPH | Calgon Vestal Div. | 1994-05-26 | 435 | 0 |
| K941163 | MON-KLENZ | Calgon Vestal Div. | 1994-05-18 | 68 | 0 |
| K931573 | VESPHENE II | Calgon Vestal Div. | 1994-05-16 | 412 | 0 |
| K932277 | LONZA FORMULATION R-82 | Calgon Vestal Div. | 1994-05-12 | 365 | 0 |
| K931599 | HYDRASORB STERILE DRESSING | Calgon Vestal Div. | 1993-07-08 | 98 | 0 |
| K926034 | EPI-LOCK WOUND DRESSING | Calgon Vestal Div. | 1993-04-20 | 140 | 0 |
| K921009 | KALTOSTAT FORTEX WOUND DRESSING | Calgon Vestal Div. | 1992-05-29 | 87 | 0 |
| K914314 | FORTEX(TM) WOUND DRESSING | Calgon Vestal Div. | 1991-10-23 | 27 | 0 |
| K910059 | KALTOSTAT WOUND DRESSING | Calgon Vestal Div. | 1991-03-20 | 70 | 0 |
| K910080 | KALTOSTAT WOUND PACKING | Calgon Vestal Div. | 1991-03-20 | 70 | 0 |
| K904488 | KALTOSTAT WOUND DRESSING | Calgon Vestal Div. | 1990-12-12 | 71 | 0 |
| K894347 | KALTOCARB WOUND DRESSING | Calgon Vestal Div. | 1989-08-23 | 40 | 0 |
| K892868 | KALTOSTAT WOUND PACKING | Calgon Vestal Div. | 1989-07-14 | 86 | 0 |
| K892364 | KALTOSTAT(TM) WOUND DRESSING | Calgon Vestal Div. | 1989-06-23 | 78 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda