Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Dale Medical Products, Inc. · Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
51 daysmedian FDA review time
85 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K082241 | THE DALE ACE CONNECTOR (ACCESS CONTROLLER FOR ENTERAL), MODE | Dale Medical Products, Inc. | 2008-10-30 | 84 | 0 |
| K994300 | NASOGASTRIC TUBE HOLDER, MODEL 160 | Dale Medical Products, Inc. | 2000-02-10 | 51 | 0 |
| K964399 | DALE ENDOTRACHEAL TUBE HOLDER 270/280 | Dale Medical Products, Inc. | 1997-01-28 | 85 | 0 |
| K961693 | DALE GASTROSTOMY TUBE HOLDER | Dale Medical Products, Inc. | 1996-07-30 | 90 | 0 |
| K951491 | DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TAB | Dale Medical Products, Inc. | 1995-04-24 | 24 | 0 |
| K914245 | DALE(R) NASAL DRESSING HOLDER (PRODUCT NO. 600) | Dale Medical Products, Inc. | 1991-12-09 | 77 | 0 |
| K905231 | DALE VENTILATOR TUBING SUPPORT FOR TRACH. VENT. | Dale Medical Products, Inc. | 1991-01-14 | 55 | 0 |
| K894586 | DALE I.V. IDENTIFIER; PRODUCT #1125 | Dale Medical Products, Inc. | 1989-08-15 | 22 | 0 |
| K873311 | DALE I.V. CONNECT. LOCK & STABILIZER (STABILOK)220 | Dale Medical Products, Inc. | 1987-11-05 | 80 | 0 |
| K864897 | DALE VENIPUNCTURE TOURNIQUET, PRODUCT NO. 1335 | Dale Medical Products, Inc. | 1987-01-12 | 28 | 0 |
| K860583 | DALE HEAD BAND ANESTHESIA CIRCUIT TUBE HOLDER 1315 | Dale Medical Products, Inc. | 1986-02-21 | 3 | 0 |
| K832946 | DALE ENDOTRACHEAL TUBE HOLDER | Dale Medical Products, Inc. | 1983-10-14 | 42 | 0 |
| K812429 | DALE COMBO TRACHEOSTOMY TUBE HOLDER | Dale Medical Products, Inc. | 1981-09-23 | 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