Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Castle Co. — Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
39 daysmedian FDA review time
73 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K870975 | MODIFIED CASTLE POWERCLAVE | Castle Co. | 1987-04-17 | 38 | 0 |
| K860263 | CASTLE 7538 FLOOR LOADING WASHER | Castle Co. | 1986-03-05 | 37 | 0 |
| K844089 | CASTLE 7515 UTENSIL/GLASSWARE WASHER | Castle Co. | 1985-01-14 | 84 | 0 |
| K834048 | BOVIE CONDUCTIVE ADHES-DISPER-ELECTRO | Castle Co. | 1984-04-04 | 133 | 0 |
| K833074 | CASTLE TEC-TEST S.M.A.R.T. PACK | Castle Co. | 1983-11-07 | 59 | 0 |
| K831595 | CASTLE MODEL 3341 & 3441 & 4141 GAS AER | Castle Co. | 1983-06-15 | 29 | 0 |
| K792660 | 1500 EO EXHAUST HOOD | Castle Co. | 1980-01-29 | 33 | 0 |
| K792649 | UNISPORE-BIOLOGICAL INDICATORS | Castle Co. | 1980-01-29 | 39 | 0 |
| K790677 | EO EVACUATING SYSTEM I | Castle Co. | 1979-05-07 | 28 | 0 |
| K781887 | 9100 DAYSTAR AND 9110 ORBITER PACKAGE | Castle Co. | 1978-12-12 | 35 | 0 |
| K781484 | CASTLE MODEL 3146 GAS AERATOR | Castle Co. | 1978-10-27 | 60 | 0 |
| K780666 | DAYSTAR SELECTRA & SELECTRA/ORBITER | Castle Co. | 1978-04-27 | 48 | 0 |
| K771865 | DAYSTAR SURG. LIGHT 9100 & ORBITER 9110 | Castle Co. | 1977-11-28 | 56 | 0 |
| K771229 | STERILIZERS, 3100 SERIES TRIM LINE | Castle Co. | 1977-08-02 | 26 | 0 |
| K770953 | MONITOR, AERATION, TEC-TEST | Castle Co. | 1977-07-14 | 50 | 0 |
| K770682 | STERILIZER, SERIES 3000, MODIFICATION TO | Castle Co. | 1977-05-20 | 39 | 0 |
| K770536 | STEAM STERILIZER, 3000 | Castle Co. | 1977-04-29 | 39 | 0 |
| K770372 | STERILIZER, STEAM, CASTLE 3000 | Castle Co. | 1977-04-05 | 39 | 0 |
| K770078 | CASTLE TEC-TEST STEAM STERI. INTEGRATOR | Castle Co. | 1977-02-28 | 46 | 0 |
| K761015 | MARKET CASTLE UNISPHERE | Castle Co. | 1977-01-21 | 73 | 0 |
| K761011 | CASTLE TEC-TEST AERATION MONITOR | Castle Co. | 1976-12-02 | 23 | 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