Cleared Traditional

K852606 - FLEBOSET 1401(60 DROPS/MI) AND FLEBOSET1400(20)

K852606 is an FDA 510(k) clearance for FLEBOSET 1401(60 DROPS/MI) AND FLEBOSET..., manufactured by Infarkem Corp.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K852606 · Infarkem Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1985
Decision
92d
Days
Class 2
Risk

K852606 is an FDA 510(k) clearance for the FLEBOSET 1401(60 DROPS/MI) AND FLEBOSET1400(20). Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Infarkem Corp. (Hartsdale, US). The FDA issued a Cleared decision on September 19, 1985 after a review of 92 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 Infarkem Corp. devices

FDA 510(k) Submission Details - K852606

510(k) Number K852606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1985
Decision Date September 19, 1985
Days to Decision 92 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 129d · This submission: 92d
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 811
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K852606.
CHURCHILL-H SCALP VEIN SET
K854436 · Churchill Corp. · Dec 1985
CHURCHILL-H VENTED IV SET
K854437 · Churchill Corp. · Dec 1985
HUBOUT
K853287 · I M, Inc. · Oct 1985
CHURCHILL VENTED IV SET
K853204 · Churchill Corp. · Sep 1985
CONTROLLED RELEASE INFUSION SYSTEM(CRIS)
K852488 · Y · Jun 1985
NAMIC CONTRAST & FLUID DELIVERY SPIKES(VARIOUS)
K852140 · North American Instrument Corp. · May 1985