Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Environmental Test Systems, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
246 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K031267 | STERICHEK BICARB PH REAGENT STRIPS | Environmental Test Systems, Inc. | 2003-12-23 | 246 | 0 |
| K003615 | STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIP | Environmental Test Systems, Inc. | 2001-02-01 | 71 | 4 |
| K001194 | STERICHEK TOTAL CHLORINE REAGENT STRIPS | Environmental Test Systems, Inc. | 2000-07-11 | 90 | 0 |
| K994226 | STERICHEK TOTAL CHLORINE REAGENT STRIPS | Environmental Test Systems, Inc. | 2000-03-22 | 98 | 0 |
| K983997 | STERICHEK TOTAL CHLORINE TEST KIT | Environmental Test Systems, Inc. | 1999-04-02 | 143 | 0 |
| K980164 | STERICHEK PERACETIC ACID REAGENT STRIPS | Environmental Test Systems, Inc. | 1998-04-16 | 90 | 0 |
| K974798 | STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS | Environmental Test Systems, Inc. | 1998-03-20 | 88 | 1 |
| K971598 | STERICHEK CHLORINE REAGENT STRIPS | Environmental Test Systems, Inc. | 1997-07-18 | 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