Cleared Traditional

K834253 - PBC IV SET NON-VENTED

K834253 is an FDA 510(k) clearance for PBC IV SET NON-VENTED, manufactured by Philadelphia Biologics Center. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K834253 · Philadelphia Biologics Center · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1984
Decision
82d
Days
Class 2
Risk

K834253 is an FDA 510(k) clearance for the PBC IV SET NON-VENTED. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Philadelphia Biologics Center (Walker, US). The FDA issued a Cleared decision on February 27, 1984 after a review of 82 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 Philadelphia Biologics Center devices

FDA 510(k) Submission Details - K834253

510(k) Number K834253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1983
Decision Date February 27, 1984
Days to Decision 82 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
47d faster than avg
Panel avg: 129d · This submission: 82d
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 856
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K834253.
HARVARD ANTI-REFLUX Y-SET
K840760 · C.R. Bard, Inc. · Apr 1984
QUIK LOK
K840878 · Abbott Laboratories · Mar 1984
LOPEZ LOCK
K840273 · Icu Medical, Inc. · Mar 1984
NITROGLYCERIN I.V. ADMINISTRATION SET
K833939 · Critikon Company, LLC · Feb 1984
INTRAVENOUS FILTER SET
K834130 · Tri-Med, Inc. · Jan 1984
CONTINU-FLO SOLUTION ADMIN. 2C9102
K834289 · Travenol Laboratories, S.A. · Jan 1984