Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IRQ — Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
80 daysmedian FDA review time
246 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K050524 | EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000 | Marda Medical, Inc. | 2005-09-14 | 196 | 0 |
| K950350 | THEMALATOR. MODELS T-4-S, T-8-S, ETC. | Whitehall/Div Columbus Mckennon Corp. | 1995-03-24 | 53 | 0 |
| K924023 | FERNO ILLE INFERNO MOIST HEAT THERAPY UT, 916/917 | Ferno | 1993-04-14 | 246 | 0 |
| K880644 | ULTRA-PAN FOR ORTHOTIC PLASTICS (7262) | Fred Sammons, Inc. | 1988-05-06 | 80 | 0 |
| K861340 | R1750 AND R1424 POWERED HEATING UNITS | Tri W-G, Inc. | 1986-05-02 | 25 | 0 |
| K832177 | PULSAIR MODEL SP-1 | Thermowave Medical Device Corp. | 1983-12-09 | 156 | 0 |
| K801625 | THERMOLATOR HEATING UNIT | Tru-Eze Mfg. Co., Inc. | 1980-07-28 | 13 | 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