DALE I.V. IDENTIFIER; PRODUCT #1125— 510(k) K894586

Name: FDA 510(k) clearance K894586
Creator: U.S. Food and Drug Administration
Published: 1989-08-15

Substantially Equivalent

Dale Medical Products, Inc.

FDA 510(k) clearance K894586 for DALE I.V. IDENTIFIER; PRODUCT #1125, Substantially Equivalent on 1989-08-15. Applicant: Dale Medical Products, Inc.. Device class: 1.

Clearance details

Applicant: Dale Medical Products, Inc.
Product code: Code KMK
Device class: Class 1
Regulation: 21 CFR 880.5210
Advisory panel: General Hospital
Date received: 1989-07-24
Decision date: 1989-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plainville, MA, US

Download summary PDF View on FDA.gov ↗

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K964399 — DALE ENDOTRACHEAL TUBE HOLDER 270/2801997-01-28
K961693 — DALE GASTROSTOMY TUBE HOLDER1996-07-30
K951491 — DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABS1995-04-24

Adverse events under product code KMK

product code KMK

Malfunction: 461
Other: 1
Total: 462

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.