Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Polymedica Industries, Inc. — Predicate Candidate Screening
16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
74 daysmedian FDA review time
191 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K964398 | SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING | Polymedica Industries, Inc. | 1997-10-24 | 354 | 0 |
| K971045 | BASIS FLEXIBLE TIP DIGITAL THERMOMETER | Polymedica Industries, Inc. | 1997-05-02 | 42 | 0 |
| K964701 | MITRAFLEX PIGMENTED WOUND DRESSING | Polymedica Industries, Inc. | 1997-02-07 | 74 | 0 |
| K963623 | SPYROFLEX PIGMENTED WOUND DRESSING | Polymedica Industries, Inc. | 1996-10-25 | 44 | 0 |
| K962991 | BASIS BABY-TEMP PACIFIER DIGITAL THEROMETER | Polymedica Industries, Inc. | 1996-09-12 | 42 | 0 |
| K955383 | SPYROCOLLOID WOUND DRESSING | Polymedica Industries, Inc. | 1995-12-13 | 19 | 0 |
| K953885 | SPYROFLEX SKIN PROTECTOR | Polymedica Industries, Inc. | 1995-11-29 | 104 | 0 |
| K952756 | MEDI-AID BASAL THERMOMETER | Polymedica Industries, Inc. | 1995-09-25 | 101 | 0 |
| K952159 | BASIS DIGITAL THERMOMETER | Polymedica Industries, Inc. | 1995-09-22 | 137 | 0 |
| K953618 | SPYROFLEX WOUND DRESSING | Polymedica Industries, Inc. | 1995-08-21 | 18 | 0 |
| K951862 | A GEL WOUND DRESSING | Polymedica Industries, Inc. | 1995-07-12 | 82 | 0 |
| K952217 | MITRAFLEX WOUND DRESSING WET-STICK | Polymedica Industries, Inc. | 1995-06-22 | 42 | 0 |
| K951730 | SPYROFOAM WOUND DRESSING | Polymedica Industries, Inc. | 1995-06-16 | 63 | 0 |
| K941673 | MEDIAID UNIVERSAL THERMOMETER | Polymedica Industries, Inc. | 1994-08-25 | 142 | 0 |
| K935783 | MITRAFLEX CAVITY WOUND DRESSING | Polymedica Industries, Inc. | 1994-02-04 | 60 | 0 |
| K932676 | SPYROFILM IQ WOUND DRESSING(WITH INERT FILLER) | Polymedica Industries, Inc. | 1993-12-10 | 191 | 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