Cleared Traditional

K832658 - DIRECTOR

K832658 is the FDA 510(k) clearance for DIRECTOR by Pharmacia, Inc.. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K832658 · Pharmacia, Inc. · General Hospital
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Oct 1983
Decision
57d
Days
Class 2
Risk

K832658 is an FDA 510(k) clearance for the DIRECTOR. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Pharmacia, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 4, 1983 after a review of 57 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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 Pharmacia, Inc. devices

Submission Details

510(k) Number K832658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1983
Decision Date October 04, 1983
Days to Decision 57 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
72d faster than avg
Panel avg: 129d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 - FMF Syringe, Piston

All 285
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K832658.
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ANGIOUROGRAPHY KIT
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9110 SYRINGE
K822774 · Cardiac Pacemakers, Inc. · Nov 1982
LARYNGEAL SYRINGE
K822185 · Kelleher Corp. · Oct 1982