Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
IMA · Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
24 daysmedian FDA review time
120 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K150139 | Rachel's Remedy | Rachel'S Remedies, LLC | 2015-05-22 | 120 | 0 |
| K950701 | WAHL SPORTS RELIEF HOT/COLD MASSAGER ROLLER | Wahl Clipper Corp. | 1995-03-24 | 37 | 0 |
| K841698 | HEAT PACK | Maddak, Inc. | 1984-05-10 | 17 | 0 |
| K832803 | STEAM PAK MOIST HEAT | Electro-Med Health Industries, Inc. | 1983-09-20 | 33 | 0 |
| K823622 | INSULATED THERMOELASTOMER MITT | Fred Sammons, Inc. | 1982-12-30 | 24 | 0 |
| K803177 | MOIST HEAT PACK | Duro-Med Ind., Inc. | 1980-12-31 | 15 | 0 |
| K791653 | REUSABLE MOIST HEAT PACK | Tru-Eze Mfg. Co., Inc. | 1979-09-07 | 24 | 0 |
| K790904 | STAO-HOTPACK | Staodynamics, Inc. | 1979-05-18 | 7 | 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