Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Spembly Medical , Ltd. — Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
47 daysmedian FDA review time
127 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K925129 | SELECTOR | Spembly Medical , Ltd. | 1993-04-23 | 192 | 0 |
| K903303 | SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES | Spembly Medical , Ltd. | 1990-10-11 | 79 | 0 |
| K901974 | SELECTOR ULTRASONIC SURGICAL ASPIRATOR | Spembly Medical , Ltd. | 1990-09-05 | 127 | 0 |
| K882568 | 130 CRYO UNIT & ASSOC. CRYOPROBES & SPRAY | Spembly Medical , Ltd. | 1988-09-27 | 97 | 0 |
| K882962 | SERIES 40 & SERIES 42 CRYOPROBES (R SERIES) | Spembly Medical , Ltd. | 1988-08-08 | 25 | 0 |
| K882963 | SPEMBLY MEDICAL 142 CRYO UNIT | Spembly Medical , Ltd. | 1988-08-08 | 25 | 0 |
| K874367 | VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF | Spembly Medical , Ltd. | 1988-01-04 | 73 | 0 |
| K840497 | OBSTETRIC PULSAR TWO CHANNEL TENS | Spembly Medical , Ltd. | 1984-04-16 | 70 | 0 |
| K832385 | CRYOPROBES MC-1400-CRYOSURG-CONSOLE | Spembly Medical , Ltd. | 1983-09-12 | 55 | 0 |
| K831963 | CRYOMEDICS NEUROSTAT | Spembly Medical , Ltd. | 1983-08-12 | 56 | 0 |
| K832334 | CRYOMEDICS 5000 CRYOSURGICAL CONSOLE | Spembly Medical , Ltd. | 1983-08-12 | 25 | 0 |
| K832140 | CRYOMEDICS 5000 CRYOPROBES | Spembly Medical , Ltd. | 1983-08-12 | 45 | 0 |
| K831950 | PULSAR #B SINGLE CHANNEL TENS-PULSAR D | Spembly Medical , Ltd. | 1983-08-01 | 47 | 0 |
| K802063 | SPEMBLY 9000 & 9300 | Spembly Medical , Ltd. | 1980-10-03 | 38 | 0 |
| K781302 | NEUROSTAT, LLOYD | Spembly Medical , Ltd. | 1978-08-15 | 18 | 0 |
| K770058 | PROBE, VACUUM INSULATED, SERIES 30 | Spembly Medical , Ltd. | 1977-02-17 | 37 | 0 |
| K760953 | DEEP FREEZE SYSTEM (DFS-30) | Spembly Medical , Ltd. | 1976-11-16 | 14 | 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