Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DZD · Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
95 daysmedian FDA review time
312 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K943421 | ORTHODONITC ELASTOMERIC SLEEVING | Jon-Ko Products, Inc. | 1995-05-23 | 312 | 0 |
| K936243 | REGENCY TUBE | Ortho Specialties | 1994-02-02 | 34 | 0 |
| K935143 | DENTAURUM STAINLESS STEEL TUBING | Dentauraum, Inc. | 1994-01-31 | 95 | 0 |
| K911399 | NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST) | Aequitron Medical, Inc. | 1991-09-19 | 174 | 0 |
| K896586 | RATE INCREASE FOR IPPB/IPV | Percussionaire Corp. | 1990-01-09 | 48 | 0 |
| K834446 | ALEXOTEK LINGUAL TUBES | Alexotek Co. | 1984-04-05 | 111 | 0 |
| K834392 | LABIAL CUSPID TUBE | Alexotek Co. | 1984-02-28 | 76 | 0 |
| K780205 | ORTHODONTIC BUCCAL TUBE | Rocky Mountain Orthodontics, Inc. | 1978-02-16 | 9 | 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