Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Polymer Technology Corp. — Predicate Candidate Screening
23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
55 daysmedian FDA review time
168 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K011945 | RIGID GAS PERMEABLE CONTACT LENS SOLUTION | Polymer Technology Corp. | 2001-09-12 | 83 | 0 |
| K980133 | BAUSCH & LOMB WETTING AND SOAKING SOLUTION | Polymer Technology Corp. | 1998-03-11 | 55 | 0 |
| K974466 | BOSTON ADVANCE CLEANER | Polymer Technology Corp. | 1998-02-19 | 85 | 0 |
| K973217 | BOSTON LIQUID ENZYMATIC CLEANER | Polymer Technology Corp. | 1997-11-24 | 89 | 0 |
| K970698 | BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENS | Polymer Technology Corp. | 1997-05-06 | 70 | 0 |
| K951552 | BOSTON CONTACT LENS CASE | Polymer Technology Corp. | 1995-06-26 | 83 | 0 |
| K943177 | BOSTON(R) 7 - 30(ENFLUFOCON A) | Polymer Technology Corp. | 1994-08-25 | 55 | 1 |
| K942365 | BOSTON VII | Polymer Technology Corp. | 1994-06-23 | 37 | 0 |
| K923438 | BOSTON CONDITIONING SOLUTION | Polymer Technology Corp. | 1992-12-28 | 168 | 0 |
| K923587 | GLUCOSE TEST SYSTEM | Polymer Technology Corp. | 1992-12-28 | 188 | 0 |
| K923437 | BOSTON CLEANER II | Polymer Technology Corp. | 1992-10-28 | 107 | 0 |
| K912580 | FIRST CHOICE | Polymer Technology Corp. | 1992-03-04 | 266 | 0 |
| K912732 | FIRST CHOICE(TM) | Polymer Technology Corp. | 1991-09-10 | 82 | 0 |
| K911792 | FIRST CHOICE(TM), MODIFICATION | Polymer Technology Corp. | 1991-05-15 | 23 | 0 |
| K893205 | FIRST CHOICE (TM) | Polymer Technology Corp. | 1989-10-06 | 163 | 0 |
| K851482 | TOURNIQUET | Polymer Technology Corp. | 1985-04-29 | 14 | 0 |
| K843523 | EMPTY SOLUTION TRANSFER CONTAINER 1000 | Polymer Technology Corp. | 1984-10-16 | 39 | 1 |
| K842057 | MACLEAN-FOGG, DISPOS-INOCULA-LOOPS | Polymer Technology Corp. | 1984-06-07 | 16 | 0 |
| K833857 | MACLEAN-FOGG, TISSUE CASSETTES | Polymer Technology Corp. | 1983-12-02 | 25 | 0 |
| K831922 | EMBEDDING RING | Polymer Technology Corp. | 1983-07-29 | 45 | 0 |
| K831921 | DISPOSABLE MICROTOME BLADES | Polymer Technology Corp. | 1983-07-29 | 45 | 0 |
| K831900 | MACLEAN-FOGG, DISP. BASE MOLD | Polymer Technology Corp. | 1983-07-28 | 44 | 0 |
| K831920 | PLASTIC TUBING CONNECTORS | Polymer Technology Corp. | 1983-07-19 | 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