Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gaymar Industries, Inc. — Predicate Candidate Screening
27 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
70 daysmedian FDA review time
287 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K100585 | MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900 | Gaymar Industries, Inc. | 2011-01-20 | 324 | 0 |
| K073675 | T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP | Gaymar Industries, Inc. | 2008-05-08 | 132 | 1 |
| K962788 | CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM | Gaymar Industries, Inc. | 1997-04-30 | 287 | 0 |
| K963067 | SOF. PRESS EPC 51 SYSTEM | Gaymar Industries, Inc. | 1997-01-28 | 174 | 0 |
| K961854 | SPR PLUS II OVERLAY SYSTEM (CL250/CL212 | Gaymar Industries, Inc. | 1996-08-09 | 87 | 0 |
| K942881 | TC 3000 | Gaymar Industries, Inc. | 1995-05-23 | 340 | 0 |
| K930345 | TC2000 POWER UNIT AND ACCESSORIES | Gaymar Industries, Inc. | 1993-08-06 | 193 | 0 |
| K914921 | SCM-3 AND ACCESSORIES | Gaymar Industries, Inc. | 1992-03-12 | 129 | 0 |
| K914805 | TC-1000, TC-1050 SYSTEM | Gaymar Industries, Inc. | 1992-01-07 | 75 | 0 |
| K914851 | CLA-1400 SYSTEM | Gaymar Industries, Inc. | 1991-11-13 | 16 | 0 |
| K912051 | MEDI-THERM (MTA-5900) & DETACHABLE HOSES | Gaymar Industries, Inc. | 1991-07-30 | 82 | 1 |
| K882092 | CLINI-CARE + PRESSURE ULCER TREATMENT SYSTEM | Gaymar Industries, Inc. | 1988-07-13 | 55 | 0 |
| K882012 | LIFESTYLE SOF. CARE GEL CHAIR CUSHION | Gaymar Industries, Inc. | 1988-05-23 | 10 | 0 |
| K852943 | NEO SHIELD | Gaymar Industries, Inc. | 1985-11-08 | 120 | 0 |
| K851027 | SOF. CARE CUSHION & SOF-CARE CUSHION COVER | Gaymar Industries, Inc. | 1985-06-18 | 98 | 0 |
| K832819 | MUL-T-PAD | Gaymar Industries, Inc. | 1983-09-26 | 38 | 0 |
| K832820 | MUL-T-BLANKET | Gaymar Industries, Inc. | 1983-09-26 | 38 | 0 |
| K810543 | NEO-WAVE SYSTEM | Gaymar Industries, Inc. | 1981-03-06 | 7 | 0 |
| K800812 | MEDI-THERM | Gaymar Industries, Inc. | 1980-04-24 | 13 | 0 |
| K780906 | AIR-FLO ALTERNATING PRESSURE PAD SYSTEM | Gaymar Industries, Inc. | 1978-08-10 | 69 | 0 |
| K780471 | GASTRIC LAVAGE KIT | Gaymar Industries, Inc. | 1978-06-02 | 70 | 0 |
| K771083 | SEQUENTIAL PRESSURE CUFF | Gaymar Industries, Inc. | 1977-07-21 | 35 | 0 |
| K760545 | WEIGHING STATION, MOBILE PATIENT | Gaymar Industries, Inc. | 1976-11-12 | 74 | 0 |
| K760804 | T-PUMP, TEMPERATURE - THERAPY PUMP | Gaymar Industries, Inc. | 1976-10-15 | 3 | 0 |
| K760706 | MUL-T-PAD | Gaymar Industries, Inc. | 1976-10-06 | 13 | 0 |
| K760527 | T-PAD | Gaymar Industries, Inc. | 1976-09-03 | 7 | 0 |
| K760315 | PAD, POLYETHER FOAM, OPEN CELL | Gaymar Industries, Inc. | 1976-08-11 | 16 | 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