Dale Medical Products, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Dale Medical Products, Inc.” (first 1981, latest 2008), across 8 product codes in 5 review panels. Median 510(k) review time under this name: 51 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CBH | Device, Fixation, Tracheal Tube | 3 | 3 |
| JAY | Support, Breathing Tube | 2 | 2 |
| KMK | Device, Intravascular Catheter Securement | 2 | 2 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 2 | 2 |
| EQH | Source, Carrier, Fiberoptic Light | 1 | 1 |
| GAX | Tourniquet, Nonpneumatic | 1 | 1 |
| KGX | Tape And Bandage, Adhesive | 1 | 1 |
| PLI | Gastrointestional Tube Holder | 1 | 1 |
Review panels
- Anesthesiology (5)
- Gastroenterology and Urology (3)
- General Hospital (2)
- General and Plastic Surgery (2)
- Ear, Nose and Throat (1)
Most recent Dale Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K082241 | THE DALE ACE CONNECTOR (ACCESS CONTROLLER FOR ENTERAL), MODEL H84104751 | KNT | 2008-10-30 | 84 |
| K994300 | NASOGASTRIC TUBE HOLDER, MODEL 160 | KNT | 2000-02-10 | 51 |
| K964399 | DALE ENDOTRACHEAL TUBE HOLDER 270/280 | CBH | 1997-01-28 | 85 |
| K961693 | DALE GASTROSTOMY TUBE HOLDER | PLI | 1996-07-30 | 90 |
| K951491 | DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABS | CBH | 1995-04-24 | 24 |
| K914245 | DALE(R) NASAL DRESSING HOLDER (PRODUCT NO. 600) | KGX | 1991-12-09 | 77 |
| K905231 | DALE VENTILATOR TUBING SUPPORT FOR TRACH. VENT. | CBH | 1991-01-14 | 55 |
| K894586 | DALE I.V. IDENTIFIER; PRODUCT #1125 | KMK | 1989-08-15 | 22 |
| K873311 | DALE I.V. CONNECT. LOCK & STABILIZER (STABILOK)220 | KMK | 1987-11-05 | 80 |
| K864897 | DALE VENIPUNCTURE TOURNIQUET, PRODUCT NO. 1335 | GAX | 1987-01-12 | 28 |
3 earlier clearances. See the full list in Caduvo.
Recalls
4 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2017-03-24.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Dale T. Dupuis (3 510(k)s)
- Dale Miller, Inc. - the Chin-Up Company (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Dale Medical Products, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Dale Medical Products, Inc.” (first 1981, latest 2008), across 8 product codes in 5 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Dale Medical Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dale Medical Products, Inc. is 51 days.
Which FDA product codes appear under Dale Medical Products, Inc.?
The most frequent FDA product codes under this applicant name are CBH (Device, Fixation, Tracheal Tube, 3); JAY (Support, Breathing Tube, 2); KMK (Device, Intravascular Catheter Securement, 2).
Next steps
- See all 13 Dale Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CBH, Dale Medical Products, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.