Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Miltex, Inc. — Predicate Candidate Screening
23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
16 daysmedian FDA review time
154 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K101653 | MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTES | Miltex, Inc. | 2010-08-02 | 52 | 0 |
| K092855 | MILTEX MEMBRANE TACK KIT | Miltex, Inc. | 2009-12-29 | 104 | 0 |
| K083796 | MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, | Miltex, Inc. | 2009-03-09 | 77 | 0 |
| K072563 | MILTEX RIGID CONTAINER SYSTEMS | Miltex, Inc. | 2008-02-12 | 154 | 0 |
| K061033 | MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS) | Miltex, Inc. | 2006-12-12 | 242 | 0 |
| K052018 | MILTEX LIGATING CLIP | Miltex, Inc. | 2005-11-04 | 101 | 0 |
| K050570 | MILTEX RIGID STERILIZATION CONTAINER SYSTEM | Miltex, Inc. | 2005-07-25 | 143 | 0 |
| K043013 | MILTEX LAPAROSCOPIC INSTRUMENTS | Miltex, Inc. | 2005-03-04 | 122 | 0 |
| K013888 | FIXATION (STEINMANN) PINS | Miltex, Inc. | 2002-05-01 | 159 | 0 |
| K954185 | RE-BAG MULTI-USE POUCH, LARGE & SMALL | Miltex, Inc. | 1995-12-04 | 89 | 0 |
| K823326 | DENTAL INSTRUMENTS - CUTTING INSTRUMENT | Miltex, Inc. | 1982-11-24 | 16 | 0 |
| K823324 | DENTAL INSTRUMENTS - PROBES | Miltex, Inc. | 1982-11-24 | 16 | 0 |
| K823316 | DENTAL INSTRUMENTS - FILES | Miltex, Inc. | 1982-11-24 | 16 | 0 |
| K823318 | DENTAL INSTRUMENTS - EXCAVATORS | Miltex, Inc. | 1982-11-24 | 16 | 0 |
| K823320 | DENTAL INSTRUMENTS - BONE CHISELS | Miltex, Inc. | 1982-11-24 | 16 | 0 |
| K823315 | DENTAL INSTRUMENTS - KNIVES | Miltex, Inc. | 1982-11-24 | 16 | 0 |
| K823323 | DENTAL INSTRUMENTS - PLASTIC INSTRUMENTS | Miltex, Inc. | 1982-11-24 | 16 | 0 |
| K823319 | DENTAL INSTRUMENTS - SCALERS | Miltex, Inc. | 1982-11-24 | 16 | 0 |
| K823321 | DENTAL INSTRUMENTS - CARVER | Miltex, Inc. | 1982-11-24 | 16 | 0 |
| K823317 | DENTAL INSTRUMENTS - EXPLORERS | Miltex, Inc. | 1982-11-24 | 16 | 0 |
| K823322 | DENTAL INSTRUMENTS - PLUGGERS | Miltex, Inc. | 1982-11-24 | 16 | 0 |
| K823325 | DENTAL INSTRUMENTS - SURGICAL FORCEPS | Miltex, Inc. | 1982-11-24 | 16 | 0 |
| K823314 | DENTAL INSTRUMENTS | Miltex, Inc. | 1982-11-24 | 16 | 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