Cleared Traditional

K941445 - EXTENSION SET WITH ANTI-SIPHON VALVE

K941445 is an FDA 510(k) clearance for EXTENSION SET WITH ANTI-SIPHON VALVE, manufactured by Pharmacia Deltec, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K941445 · Pharmacia Deltec, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1994
Decision
97d
Days
Class 2
Risk

K941445 is an FDA 510(k) clearance for the EXTENSION SET WITH ANTI-SIPHON VALVE. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Pharmacia Deltec, Inc. (St. Paul, US). The FDA issued a Cleared decision on June 29, 1994 after a review of 97 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 Pharmacia Deltec, Inc. devices

FDA 510(k) Submission Details - K941445

510(k) Number K941445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1994
Decision Date June 29, 1994
Days to Decision 97 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
32d faster than avg
Panel avg: 129d · This submission: 97d
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 791
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K941445.
IVAC VENTED SYRINGE ADAPTER ADMINISTRATION SETS
K934095 · Y · Aug 1994
PROVIDER PUMP SET W/INFUSION CARTRIDGE
K934513 · Abbott Laboratories · Jul 1994
SOF-SET QR INFUSION SETS, MODELS MMT-115 AND MMT-116
K942181 · Medtronic Minimed · Jul 1994
IVAC NEEDLELESS INFECTION VALVE ADMINISTRATION SET
K940897 · Y · Jun 1994
ENERGIZED DRUG CONTAINER SYSTEM
K934119 · Abbott Laboratories · Jun 1994
ISOFLUX IXP FLOW REGULATOR
K925731 · Ferguson Medical · May 1994