Gaymar Industries, Inc.: FDA clearances and approvals
Gaymar Industries, Inc. has 27 FDA 510(k) clearances (first 1976, latest 2011), across 15 product codes in 4 review panels. Median 510(k) review time: 70 days. openFDA lists 1 product recall by a recalling firm named Gaymar Industries, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DWJ | System, Thermal Regulating | 6 | 6 |
| ILO | Pack, Hot Or Cold, Water Circulating | 5 | 5 |
| FNM | Mattress, Air Flotation, Alternating Pressure | 3 | 3 |
| JOW | Sleeve, Limb, Compressible | 2 | 2 |
| FAT | Bougie, Esophageal, And Gastrointestinal, Gastro-Urology | 1 | 1 |
| FMT | Warmer, Infant Radiant | 1 | 1 |
| FNJ | Bed, Manual | 1 | 1 |
| FRW | Scale, Patient | 1 | 1 |
| IKY | Mattress, Flotation Therapy, Non-Powered | 1 | 1 |
| IKZ | Bed, Patient Rotation, Powered | 1 | 1 |
Plus 5 more product codes.
Review panels
Most recent Gaymar Industries, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K100585 | MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900 | DWJ | 2011-01-20 | 324 |
| K073675 | T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP | ILO | 2008-05-08 | 132 |
| K962788 | CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM | IKZ | 1997-04-30 | 287 |
| K963067 | SOF. PRESS EPC 51 SYSTEM | JOW | 1997-01-28 | 174 |
| K961854 | SPR PLUS II OVERLAY SYSTEM (CL250/CL212 | FNM | 1996-08-09 | 87 |
| K942881 | TC 3000 | DWJ | 1995-05-23 | 340 |
| K930345 | TC2000 POWER UNIT AND ACCESSORIES | DWJ | 1993-08-06 | 193 |
| K914921 | SCM-3 AND ACCESSORIES | IKY | 1992-03-12 | 129 |
| K914805 | TC-1000, TC-1050 SYSTEM | DWJ | 1992-01-07 | 75 |
| K914851 | CLA-1400 SYSTEM | IOQ | 1991-11-13 | 16 |
17 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2004-10-25.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Gaymar Industries, Inc. have?
Gaymar Industries, Inc. has 27 FDA 510(k) clearances (first 1976, latest 2011), across 15 product codes in 4 review panels.
How long does FDA take to clear Gaymar Industries, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Gaymar Industries, Inc.'s cleared 510(k)s is 70 days.
What devices does Gaymar Industries, Inc. make?
Its most frequent FDA product codes are DWJ (System, Thermal Regulating, 6); ILO (Pack, Hot Or Cold, Water Circulating, 5); FNM (Mattress, Air Flotation, Alternating Pressure, 3).
Has Gaymar Industries, Inc. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Gaymar Industries, Inc; the most recent began 2004-10-25. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 27 Gaymar Industries, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DWJ, Gaymar Industries, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.