Cleared Traditional

K896561 - EXTENSION SET

K896561 is an FDA 510(k) clearance for EXTENSION SET, manufactured by Westmark, Sterile Packing Systems, Inc. (Sps). The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K896561 · Westmark, Sterile Packing Systems, Inc. (Sps) · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1990
Decision
76d
Days
Class 2
Risk

K896561 is an FDA 510(k) clearance for the EXTENSION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Westmark, Sterile Packing Systems, Inc. (Sps) (Grand Rapids, US). The FDA issued a Cleared decision on February 1, 1990 after a review of 76 days - a notably fast clearance cycle.

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

View all Westmark, Sterile Packing Systems, Inc. (Sps) devices

FDA 510(k) Submission Details - K896561

510(k) Number K896561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1989
Decision Date February 01, 1990
Days to Decision 76 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
53d faster than avg
Panel avg: 129d · This submission: 76d
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 644
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K896561.
ADVANCE ADMINISTRATION SETS (VARYING LENGTH)
K900188 · Advance Medical Designs, Inc. · May 1990
IV BIFURCATED EXTENSION SET
K900426 · Marquette Medical, Inc. · Feb 1990
IV TRIFURCATED EXTENSION SET
K900427 · Marquette Medical, Inc. · Feb 1990
GRIPPER PORT-A-CATH NEEDLE WITH STOPCOCK
K896346 · Pharmacia Deltec, Inc. · Jan 1990
AVI MODEL 2012, 1.2 MICRON FILTER IV ADMINISTRA.
K896161 · 3M Company · Jan 1990
VOLUMETRIC PUMP SOLUTION SET W/INTEGRAL AIRWAY
K893646 · Baxter Healthcare Corp · Dec 1989