Cleared Traditional

K973916 - NP MEDICAL CAPLESS LUER ACTIVATED VALVE

K973916 is an FDA 510(k) clearance for NP MEDICAL CAPLESS LUER ACTIVATED VALVE, manufactured by Np Medical, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K973916 · Np Medical, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Mar 1998
Decision
146d
Days
Class 2
Risk

K973916 is an FDA 510(k) clearance for the NP MEDICAL CAPLESS LUER ACTIVATED VALVE. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Np Medical, Inc. (Clinton, US). The FDA issued a Cleared decision on March 9, 1998 after a review of 146 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 Np Medical, Inc. devices

FDA 510(k) Submission Details - K973916

510(k) Number K973916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1997
Decision Date March 09, 1998
Days to Decision 146 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 129d · This submission: 146d
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 534
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K973916.
SOLUTION ADMINISTRATION SET WITH CAPPED LUER ACTIVATED VALVE
K974571 · Baxter Healthcare Corp · May 1998
EXTENSION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE CADD ADMINISTRATION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE
K980583 · Sims Deltec, Inc. · Apr 1998
DUAL LUER LOCK CAP
K981318 · Baxter Healthcare Corp · Apr 1998
MINIMED SOF-SET ULTIMATE QR INFUSION SET MODELS 315 AND 316
K974163 · Medtronic Minimed · Feb 1998
SMARTVALVE
K974589 · Icu Medical, Inc. · Jan 1998
V3 VALVE
K974145 · B.Braun Medical, Inc. · Jan 1998