Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Suncoast Medical Manufacturers, Inc. · Predicate Candidate Screening
31 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
93 daysmedian FDA review time
232 days90th percentile
31clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K841459 | REPLACE-A-TIP ADJUST. LOW TEMP.- | Suncoast Medical Manufacturers, Inc. | 1984-12-07 | 242 | 0 |
| K841509 | REPLACE-A-TIP ADJUSTABLE HIGH TEMP. | Suncoast Medical Manufacturers, Inc. | 1984-12-07 | 240 | 0 |
| K841603 | ADJUST-A-TEMP MICRO | Suncoast Medical Manufacturers, Inc. | 1984-12-07 | 232 | 0 |
| K841604 | ADJUST-A-TEMP HIGH TEMPERATURE | Suncoast Medical Manufacturers, Inc. | 1984-12-07 | 232 | 0 |
| K841591 | PYRO-TIP | Suncoast Medical Manufacturers, Inc. | 1984-10-31 | 196 | 0 |
| K840376 | SURG-A STAT LOOP TIP | Suncoast Medical Manufacturers, Inc. | 1984-10-26 | 273 | 0 |
| K840370 | SURG-A-STAT VASECTOMY TIP | Suncoast Medical Manufacturers, Inc. | 1984-07-23 | 178 | 0 |
| K840375 | SURG-A-STAT LOOP TIP 15 | Suncoast Medical Manufacturers, Inc. | 1984-07-23 | 178 | 0 |
| K840377 | SURG-A-STAT CARDIOVASCULAR TIP | Suncoast Medical Manufacturers, Inc. | 1984-07-23 | 178 | 0 |
| K840387 | SURG-A-STAT LOOP TIP 2 | Suncoast Medical Manufacturers, Inc. | 1984-07-23 | 175 | 0 |
| K841588 | SUN-LITE WHITE SPOT | Suncoast Medical Manufacturers, Inc. | 1984-05-22 | 34 | 0 |
| K841589 | C-LITE | Suncoast Medical Manufacturers, Inc. | 1984-05-22 | 34 | 0 |
| K840425 | OPTHERM FINE TIP | Suncoast Medical Manufacturers, Inc. | 1984-05-09 | 99 | 0 |
| K840426 | OPTHERM EXTRA FINE TIP | Suncoast Medical Manufacturers, Inc. | 1984-05-09 | 99 | 0 |
| K840427 | SUN-LITE BLUE SPOT | Suncoast Medical Manufacturers, Inc. | 1984-05-09 | 99 | 0 |
| K840428 | SUN-LITE PEN LIGHT | Suncoast Medical Manufacturers, Inc. | 1984-05-09 | 99 | 0 |
| K840430 | SUN-LITE WHITE SLIT | Suncoast Medical Manufacturers, Inc. | 1984-05-09 | 99 | 0 |
| K840492 | SUN-LITE BLUE SLIT | Suncoast Medical Manufacturers, Inc. | 1984-05-09 | 93 | 0 |
| K841325 | REPLACE-A-TIP RECHARG. LOW TEMP. | Suncoast Medical Manufacturers, Inc. | 1984-05-09 | 37 | 0 |
| K841326 | REPLACE-A-TIP RECHARGEABLE HIGH TEMP | Suncoast Medical Manufacturers, Inc. | 1984-05-09 | 37 | 0 |
| K840433 | REPLACE-A-TIP HIGH TEMP. CAUTERY | Suncoast Medical Manufacturers, Inc. | 1984-04-25 | 84 | 0 |
| K840434 | REPLACE-A-TIP LOW TEMP. CAUTERY | Suncoast Medical Manufacturers, Inc. | 1984-04-25 | 84 | 0 |
| K840371 | FLEXIBLE ILLUMINATOR 5 | Suncoast Medical Manufacturers, Inc. | 1984-04-24 | 88 | 0 |
| K840372 | FLEXIBLE ILLUMINATOR 15 | Suncoast Medical Manufacturers, Inc. | 1984-04-24 | 88 | 0 |
| K840373 | FLEXIBLE ILLUMINATOR 10 | Suncoast Medical Manufacturers, Inc. | 1984-04-24 | 88 | 0 |
| K840493 | SURG A STAT FINE TIP 5 | Suncoast Medical Manufacturers, Inc. | 1984-04-23 | 77 | 0 |
| K840585 | SURG-A-STAT FINE TIP 2 | Suncoast Medical Manufacturers, Inc. | 1984-04-23 | 75 | 0 |
| K840429 | SUN-LITE ONE MILLIMETER | Suncoast Medical Manufacturers, Inc. | 1984-04-13 | 73 | 0 |
| K840456 | SUN-LITE 1 | Suncoast Medical Manufacturers, Inc. | 1984-04-13 | 71 | 0 |
| K840374 | SURG-A-STAT FINE TIP | Suncoast Medical Manufacturers, Inc. | 1984-01-27 | 0 | 0 |
| K840378 | ADJUST-A-TEMP EXTRA FINE TIP | Suncoast Medical Manufacturers, Inc. | 1984-01-27 | 0 | 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