Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IMC · Predicate Candidate Screening
12 FDA 510(k) clearances under this product code; the 50 most recent screened below.
52 daysmedian FDA review time
85 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K093100 | REVLON RVSP3501 SPA MOISTURESTAY PARAFFIN BATH (TYPE SPB3752 | Shenzhen Comfort Technology Co., Ltd. | 2009-11-24 | 54 | 0 |
| K022626 | MOISTURESTAY (REVLON) | Raymond Industrial, Ltd. | 2002-10-29 | 83 | 0 |
| K013707 | SOFTIQUE, MODEL GI 11001 | Global TV Concepts, Ltd. | 2002-02-01 | 85 | 0 |
| K013328 | REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600 | Remington Products Company, LLC | 2001-12-03 | 59 | 0 |
| K001860 | PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA | Homedics, Inc. | 2000-08-10 | 52 | 0 |
| K991427 | PARAMED PARAFFIN WARMER | Divi Intl. Co. | 1999-08-13 | 112 | 0 |
| K980718 | PARA-CARE | Chattanooga Group, Inc. | 1998-03-27 | 31 | 0 |
| K861344 | R1124 & R1686 PARAFFIN | Tri W-G, Inc. | 1986-05-27 | 50 | 0 |
| K861346 | R1363 PARAFFIN | Tri W-G, Inc. | 1986-05-02 | 25 | 0 |
| K842423 | PARA THERM BATH | Grimm Scientific Industries, Inc. | 1984-06-28 | 8 | 0 |
| K833631 | THERMAMED BATH | Bernlit Enterprises, Inc. | 1983-11-28 | 42 | 0 |
| K770170 | MADDATHERM PARAFFIN BATH | Techhnilab Instruments, Inc. | 1977-01-28 | 3 | 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