Dale Medical Products, Inc.
New London, CT, US
DALE MEDICAL PRODUCTS, INC. appears in FDA device records in New London, CT. FDA records list 13 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 13 510(k) clearances for Dale Medical Products, Inc. between 1981 and 2008. The busiest year on record is 1987, with 2. The most recent is 2008, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 1 |
| 1983 | 1 |
| 1986 | 1 |
| 1987 | 2 |
| 1989 | 1 |
| 1991 | 2 |
| 1995 | 1 |
| 1996 | 1 |
| 1997 | 1 |
| 2000 | 1 |
| 2008 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K082241 | THE DALE ACE CONNECTOR (ACCESS CONTROLLER FOR ENTERAL), MODEL H84104751 | KNT | Substantially Equivalent | |
| K994300 | NASOGASTRIC TUBE HOLDER, MODEL 160 | KNT | Substantially Equivalent | |
| K964399 | DALE ENDOTRACHEAL TUBE HOLDER 270/280 | CBH | Substantially Equivalent | |
| K961693 | DALE GASTROSTOMY TUBE HOLDER | PLI | Substantially Equivalent | |
| K951491 | DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABS | CBH | Substantially Equivalent | |
| K914245 | DALE(R) NASAL DRESSING HOLDER (PRODUCT NO. 600) | KGX | Substantially Equivalent | |
| K905231 | DALE VENTILATOR TUBING SUPPORT FOR TRACH. VENT. | CBH | Substantially Equivalent | |
| K894586 | DALE I.V. IDENTIFIER; PRODUCT #1125 | KMK | Substantially Equivalent | |
| K873311 | DALE I.V. CONNECT. LOCK & STABILIZER (STABILOK)220 | KMK | Substantially Equivalent | |
| K864897 | DALE VENIPUNCTURE TOURNIQUET, PRODUCT NO. 1335 | GAX | Substantially Equivalent | |
| K860583 | DALE HEAD BAND ANESTHESIA CIRCUIT TUBE HOLDER 1315 | JAY | Substantially Equivalent | |
| K832946 | DALE ENDOTRACHEAL TUBE HOLDER | JAY | Substantially Equivalent | |
| K812429 | DALE COMBO TRACHEOSTOMY TUBE HOLDER | EQH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1214422 | 1214422 | DALE MEDICAL PRODUCTS, INC. | 3 State Pier Rd, New London, CT 06320 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- PUKAdministration Set Securement Device
- FSDBinder, Abdominal
- HEFBinder, Breast
- CBHDevice, Fixation, Tracheal Tube
- KMKDevice, Intravascular Catheter Securement
- PLIGastrointestional Tube Holder
- EYJHolder, Ureteral Catheter
- LCNScraper, Tongue
- EQHSource, Carrier, Fiberoptic Light
- FYHSplint, Extremity, Noninflatable, External, Sterile
- JAYSupport, Breathing Tube
- KGXTape And Bandage, Adhesive
- GAXTourniquet, Nonpneumatic
- KNTTubes, Gastrointestinal (And Accessories)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1928-2017 | Dale Medical Stabilock Endotracheal Adhesive Base Product # 273 The Dale Stabilock Endotracheal Tube Bolder 270 is a 2 piece device consisting of an adhesive base, Dale product number 273, that attaches to the patient's skin and a cushioned neckband with tube channel that attaches with hook & loop closures. The 270 is used to secure and stabilize endotracheal tubes, preventing unnecessary movement which can help prevent accidental .extubation | ET Tube Holders contain an adhesive faceplate that may lose its adhesive properties and will not adhere to the patient's face. | Class II | Terminated | |
| Z-1927-2017 | Dale Medical Stabilock Endotracheal Tube Holder Product # 270 The Dale Stabilock Endotracheal Tube Bolder 270 is a 2 piece device consisting of an adhesive base, Dale product number 273, that attaches to the patient's skin and a cushioned neckband with tube channel that attaches with hook & loop closures. The 270 is used to secure and stabilize endotracheal tubes, preventing unnecessary movement which can help prevent accidental .extubation | ET Tube Holders contain an adhesive faceplate that may lose its adhesive properties and will not adhere to the patient's face. | Class II | Terminated | |
| Z-0447-2008 | Dale 242 Blue (Neonate, Infants and Small Children) Tracheostomy Tube Holder, Product Number: H84102421, Dale Medical Products, Inc., Plainville, MA 02762 | Revised Labeling : Instructions For use: "Do not trim fastener hook tabs. " Trimming can cause tabs to disengage at the trach plate | Terminated | ||
| Z-0446-2008 | Dale 240 Blue (Adults) Tracheostomy Tube Holder, Product Number: H84102401, Dale Medical Products, Inc., Plainville, MA 02762 | Revised Labeling : Instructions For use: "Do not trim fastener hook tabs. " Trimming can cause tabs to disengage at the trach plate | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain