Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Polymer Technology Intl. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
312 daysmedian FDA review time
329 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K953672 | FIRST CHOICE URINARY TRACT INFECTION TEST STRIPS | Polymer Technology Intl. | 1996-07-01 | 329 | 0 |
| K953661 | FIRST CHOICE GLUCOSE URINE TEST STRIPS | Polymer Technology Intl. | 1996-06-14 | 312 | 0 |
| K953662 | FIRST CHOICE KETONES URINE TEST STRIPS | Polymer Technology Intl. | 1996-06-14 | 312 | 0 |
| K953680 | FIRST CHOICE GLUCOSE & KETONES URINE TEST STRIPS | Polymer Technology Intl. | 1996-06-12 | 310 | 0 |
| K946166 | FIRST CHOICE(TM) TEST STRIP | Polymer Technology Intl. | 1995-11-08 | 324 | 0 |
| K950628 | FIRST CHOICE TEST STRIP | Polymer Technology Intl. | 1995-11-08 | 268 | 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