Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Applied Polytechnology, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
53 daysmedian FDA review time
87 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K860483 | FILTRA-CHECK-UTI | Applied Polytechnology, Inc. | 1986-04-04 | 53 | 0 |
| K843833 | BACTERIURIA DETECT DEVICE, MULTI SAMPLER | Applied Polytechnology, Inc. | 1984-11-29 | 59 | 0 |
| K843834 | BACTERIURIA DETECT. DEVICE APTEK II | Applied Polytechnology, Inc. | 1984-11-29 | 59 | 0 |
| K843359 | URINE TRANSPORT KIT | Applied Polytechnology, Inc. | 1984-09-27 | 31 | 0 |
| K843316 | INDOLE SPOT TEST KIT 270-25 | Applied Polytechnology, Inc. | 1984-09-11 | 18 | 0 |
| K840257 | RAPID IMMUNO-ASSAY SYS | Applied Polytechnology, Inc. | 1984-04-19 | 87 | 0 |
| K834264 | REVERSE-FLOW SYSTEM | Applied Polytechnology, Inc. | 1984-01-13 | 36 | 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