Cleared Traditional

PBC SYRINGE IRRIGATING (K834256) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K834256 · Philadelphia Biologics Center · General Hospital
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Mar 1984
Decision
107d
Days
Class 2
Risk

K834256 is an FDA 510(k) clearance for the PBC SYRINGE IRRIGATING. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Philadelphia Biologics Center (Mchenry, US). The FDA issued a Cleared decision on March 23, 1984 after a review of 107 days - within the typical 510(k) review window.

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: 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 Philadelphia Biologics Center devices

Submission Details

510(k) Number K834256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1983
Decision Date March 23, 1984
Days to Decision 107 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
22d faster than avg
Panel avg: 129d · This submission: 107d
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 240
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K834256.
MONOJECT STERILE 12CC SYRINGES, W/WO NEEDLES
K851089 · Sherwood Medical Co. · Apr 1985
MONOJECT STERILE 1/2 CC & 1CC SYRINGES W & W/O NEE
K851090 · Sherwood Medical Co. · Apr 1985
SYRINGE W/NEEDLE COMBIN & SYRINGE ONLY
K844106 · Abco Dealers, Inc. · Jan 1985
HYPODERMIC SYRINGES & NEEDLES
K834548 · Cordis Corp. · Mar 1984
DIRECTOR
K832658 · Pharmacia, Inc. · Oct 1983
U-100 INSULIN SYRINGE
K822083 · Terumo Medical Corp. · Aug 1982