Cleared Traditional

K970855 - CLAVE CONNECTOR

K970855 is an FDA 510(k) clearance for CLAVE CONNECTOR, manufactured by Icu Medical, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K970855 · Icu Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
106d
Days
Class 2
Risk

K970855 is an FDA 510(k) clearance for the CLAVE CONNECTOR. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Icu Medical, Inc. (San Clemente, US). The FDA issued a Cleared decision on June 24, 1997 after a review of 106 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Icu Medical, Inc. devices

FDA 510(k) Submission Details - K970855

510(k) Number K970855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1997
Decision Date June 24, 1997
Days to Decision 106 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
23d faster than avg
Panel avg: 129d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FPA Set, Administration, Intravascular

All 772
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K970855.
NEEDLE-FREE VALVED CONNECTOR AND CAP
K964439 · Bmw Medical, Inc. · Jul 1997
LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE
K971293 · Abbott Mfg., Inc. · Jun 1997
VENTED I.V. SET
K965027 · Jms Co., Ltd. · Jun 1997
CONTINU-FLO SOLUTION SET
K971701 · Baxter Healthcare Corp · Jun 1997
GORE IRRIGATION SET
K964067 · W.L. Gore & Associates, Inc. · Jun 1997
TAMARYN I.V. FLOW REGULATOR EXTENSION SET
K971066 · Tamaryn Medical Systems, Inc. · Jun 1997