Cleared Traditional

K873311 - DALE I.V. CONNECT. LOCK & STABILIZER (STABILOK)220

K873311 is an FDA 510(k) clearance for DALE I.V. CONNECT. LOCK & STABILIZER (S..., manufactured by Dale Medical Products, Inc.. The device is a Class 1 General Hospital device with product code KMK cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K873311 · Dale Medical Products, Inc. · General Hospital
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Nov 1987
Decision
80d
Days
Class 1
Risk

K873311 is an FDA 510(k) clearance for the DALE I.V. CONNECT. LOCK & STABILIZER (STABILOK)220. Classified as Device, Intravascular Catheter Securement (product code KMK), Class I - General Controls.

Submitted by Dale Medical Products, Inc. (Plainville, US). The FDA issued a Cleared decision on November 5, 1987 after a review of 80 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5210 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K873311

510(k) Number K873311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1987
Decision Date November 05, 1987
Days to Decision 80 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 129d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

KMK Device Classification - Class 1, General Controls

Product Code KMK Device, Intravascular Catheter Securement
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5210
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KMK Device, Intravascular Catheter Securement

All 47
Devices cleared under the same product code (KMK) and FDA review panel - the closest regulatory comparables to K873311.
VITAPATCH CATH. SECUREMENT DEVICE W/CHLORHEXIDINE
K896046 · Vitaphore Corp. · Jan 1990
JOHNSON & JOHNSON TUBE SECUREMENT DEVICE
K895431 · Johnson & Johnson Patient Care, Inc. · Oct 1989
DALE I.V. IDENTIFIER
K894586 · Dale Medical Products, Inc. · Aug 1989
TIMLEINE(TM) VENIPUNCTURE SYSTEM
K870770 · Ipax, Inc. · Apr 1987
E-Z HOLD - #4060
K864190 · John F. Greer Co., Inc. · Jan 1987
IV BAND (INTRAVENOUS CATHETER ASSESORY)
K860706 · T. G. & E. Medical · Mar 1986
K873311 · DALE I.V. CONNECT. LOCK & STABILIZER (STABILOK)220
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