Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Applied Medical Devices, Inc. · Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
79 daysmedian FDA review time
170 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K843885 | PERCUTANEOUS ASPIRATION BIOPSY TRAY | Applied Medical Devices, Inc. | 1984-12-19 | 78 | 0 |
| K843883 | STERILE PERCUTANEOUS TRANSHEPATIC CHOLAN | Applied Medical Devices, Inc. | 1984-12-13 | 72 | 0 |
| K843884 | GENERAL UTILITY TRAY SYSTEM | Applied Medical Devices, Inc. | 1984-12-13 | 72 | 0 |
| K840904 | ACCU-CULT FECAL OCCULT BLOOD TEST | Applied Medical Devices, Inc. | 1984-08-16 | 170 | 0 |
| K842591 | ULTRASOUND PROBE COVERS-STERILE | Applied Medical Devices, Inc. | 1984-07-23 | 20 | 0 |
| K833720 | TRANSTHORACIC/TRANSABDOMINAL-TRAY | Applied Medical Devices, Inc. | 1984-05-30 | 219 | 0 |
| K840334 | CHEMONUCLEOLYSIS/DISCOGRAPHY TRAY | Applied Medical Devices, Inc. | 1984-04-13 | 79 | 0 |
| K833438 | PREPACELL-STERILE-BONE MARROW ASPIR | Applied Medical Devices, Inc. | 1984-02-09 | 127 | 0 |
| K833719 | PREPACELL THIN NEEDLE ASPIRATION TRAY | Applied Medical Devices, Inc. | 1984-01-25 | 93 | 0 |
| K802406 | CYTOTRAN I BONE MARROW ASPIRATION SYSTEM | Applied Medical Devices, Inc. | 1981-01-15 | 104 | 0 |
| K791660 | PREPACELL-BONE MARROW SAMPLER | Applied Medical Devices, Inc. | 1979-09-12 | 22 | 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