Cleared Traditional

K964283 - AUTOPRIME

K964283 is an FDA 510(k) clearance for AUTOPRIME, manufactured by Arbor Technologies, Inc.. The device is a Class 2 General Hospital device with product code FPB cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K964283 · Arbor Technologies, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
86d
Days
Class 2
Risk

K964283 is an FDA 510(k) clearance for the AUTOPRIME. Classified as Filter, Infusion Line (product code FPB), Class II - Special Controls.

Submitted by Arbor Technologies, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on January 22, 1997 after a review of 86 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 Arbor Technologies, Inc. devices

FDA 510(k) Submission Details - K964283

510(k) Number K964283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1996
Decision Date January 22, 1997
Days to Decision 86 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 129d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPB Device Classification - Class 2, Special Controls

Product Code FPB Filter, Infusion Line
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 - FPB Filter, Infusion Line

All 71
Devices cleared under the same product code (FPB) and FDA review panel - the closest regulatory comparables to K964283.
NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER
K113227 · Baxter Healthcare Corp · Dec 2011
PALL SUPOR AEF FILTER
K993379 · Pall Corp. · Dec 1999
0.2 U BACTERIAL FILTER
K974661 · Sims Deltec, Inc. · Feb 1998
PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER)
K954331 · Pall Biomedical Products Co. · Jan 1997
40 MICRON BLOOD TRANSFUSION FILTER
K941628 · Douglas Medical Products Corp. · Feb 1995
PHARMASSURE LARGE VOLUME TRANSFER FILTERS
K943127 · Gelman Sciences, Inc. · Sep 1994