Cleared Traditional

K940127 - CENTERMARK SECURING WINGS

K940127 is an FDA 510(k) clearance for CENTERMARK SECURING WINGS, manufactured by Menlo Care, Inc.. The device is a Class 1 General Hospital device with product code KMK cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K940127 · Menlo Care, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
30d
Days
Class 1
Risk

K940127 is an FDA 510(k) clearance for the CENTERMARK SECURING WINGS. Classified as Device, Intravascular Catheter Securement (product code KMK), Class I - General Controls.

Submitted by Menlo Care, Inc. (Menlo Park, US). The FDA issued a Cleared decision on February 9, 1994 after a review of 30 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 - K940127

510(k) Number K940127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1994
Decision Date February 09, 1994
Days to Decision 30 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 129d · This submission: 30d
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 63
Devices cleared under the same product code (KMK) and FDA review panel - the closest regulatory comparables to K940127.
IMMOBILE STERILE AND IMMOBILE A/C STERILE
K941940 · Tnt Moborg Intl. , Ltd. · Jul 1994
CONMED VENI-GARD I.V. DRESSING
K935389 · Conmedcorp · Mar 1994
K-LOK CATHETER SECUREMENT DEVICE MODIFICATION
K935252 · K-Lok, Inc. · Feb 1994
SECURODRIP (TM) I.V. ARMBOARD
K932757 · Op-Co Medical Products , Ltd. · Dec 1993
DUODERM TRANSPARENT HYDROCOLLOID DRESSING
K925992 · Convatec, A Division of E.R. Squibb & Sons · Oct 1993
IV COMFORT PAD
K930663 · D.J. Scott Mfg., Inc. · Sep 1993
K940127 · CENTERMARK SECURING WINGS
Download PDF FDA Summary Menlo Care, Inc.