Cleared Traditional

K921576 - STRATO LIFEPORT LARGE BORE INFUSION SET

K921576 is an FDA 510(k) clearance for STRATO LIFEPORT LARGE BORE INFUSION SET, manufactured by Starto Medical Corp.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K921576 · Starto Medical Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1992
Decision
172d
Days
Class 2
Risk

K921576 is an FDA 510(k) clearance for the STRATO LIFEPORT LARGE BORE INFUSION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Starto Medical Corp. (Beverly, US). The FDA issued a Cleared decision on September 21, 1992 after a review of 172 days - an extended review 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: 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 Starto Medical Corp. devices

FDA 510(k) Submission Details - K921576

510(k) Number K921576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1992
Decision Date September 21, 1992
Days to Decision 172 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
43d slower than avg
Panel avg: 129d · This submission: 172d
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 833
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K921576.
SUBCUTANEOUS INFUSION SET
K920537 · Marquette Medical, Inc. · Oct 1992
LIFEPORT INFUSION SET AND INFUSION SET W/ Y SITE
K921674 · Strato Medical Corp. · Sep 1992
CLAVE CONNECTOR
K915571 · Icu Medical, Inc. · Sep 1992
SOLUTION ADMINISTRATION SET
K921391 · Douglas Medical Products Corp. · Sep 1992
MERIT ADMINISTRATION SET
K915678 · Merit Medical Systems, Inc. · Jul 1992
CONTINU-FLO(R) SOLUTION SET
K921703 · Baxter Healthcare Corp · Jun 1992