Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Wescor, Inc. — Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
52 daysmedian FDA review time
279 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|
| K121823 | CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLO | Wescor, Inc. | 2013-03-27 | 279 | 0 |
| K010031 | NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM | Wescor, Inc. | 2001-03-20 | 76 | 0 |
| K863395 | WESCOR SWEAT.CHEK SWEAT CONDUCTIVITY ANALYZER | Wescor, Inc. | 1988-05-24 | 629 | 0 |
| K881592 | WESCOR MODEL 7300 AEROSPRAY GRAM STAINER | Wescor, Inc. | 1988-05-13 | 31 | 0 |
| K881512 | WESCOR GRAM STAIN PACK FOR MODEL 7300 AEROSPRAY | Wescor, Inc. | 1988-04-18 | 7 | 0 |
| K880544 | WESCOR STAIN CONCENTRATE FOR MODEL 7100 AEROSPRAY | Wescor, Inc. | 1988-04-01 | 52 | 0 |
| K853973 | WESCOR MODEL 3700 WEBSTER SWEAT INDUCER | Wescor, Inc. | 1985-10-16 | 20 | 0 |
| K834214 | WESCOR 5500 VAPOR PRESSURE OSMOMETER | Wescor, Inc. | 1984-03-30 | 116 | 0 |
| K834208 | COLLOID OSMOMETER 4400 | Wescor, Inc. | 1984-03-23 | 109 | 2 |
| K840472 | SYS MACRODUCT SWEAT COLLECTION SYS 3600 | Wescor, Inc. | 1984-03-19 | 45 | 0 |
| K830429 | WEIL PERFUSOMETER #100 | Wescor, Inc. | 1983-10-31 | 264 | 0 |
| K833295 | WESCOR 7100 AEROSPRAY SLIDE STAINER | Wescor, Inc. | 1983-10-31 | 38 | 0 |
| K833260 | STAIN PACK FOR AEROSPRAY SLIDE STAINER | Wescor, Inc. | 1983-10-28 | 35 | 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