Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
DYX — Predicate Candidate Screening
11 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
260 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K162046 | MINNE TIES MMF Suture System | Summit Medical, Inc. | 2017-04-11 | 260 | 0 |
| K061271 | ERCH ARCH BAR, MODEL 38-690-00 | KLS-Martin L.P. | 2006-06-30 | 56 | 0 |
| K031207 | SAFETY RELEASE ARCH BAR KIT | Casey Surgical, LLC | 2003-07-15 | 90 | 0 |
| K030605 | RAPID IMF | Zygomatics , Ltd. | 2003-06-27 | 122 | 0 |
| K990212 | LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100 | Doctor'S Research Group, Inc. | 1999-09-14 | 235 | 0 |
| K991004 | SYNTHES QUICK LOCK IMF SYSTEM | Synthes (Usa) | 1999-06-23 | 90 | 0 |
| K925106 | IMPLANTABLE PULSE GENERATORS | Medtronic Vascular | 1993-10-06 | 362 | 0 |
| K925712 | RELIANCE SHORT STICK TIE | Reliance Orthodontic Products, Inc. | 1993-01-11 | 60 | 0 |
| K910090 | DIMAC WIRES | Instrumentations Unltd. | 1991-07-25 | 197 | 0 |
| K863799 | JAW FIXATION ASSEMBLY | Medical Products & Research, Inc. | 1986-10-14 | 15 | 0 |
| K820944 | DENTAL ARCH BAR | Unisplint Corp. | 1982-05-05 | 29 | 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