Cleared Traditional

HAC AUTOLOGY CENTERS DISPENSING KIT FOR FIB.CON. (K880963) - FDA 510(k) Clearance

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

K880963 · Buckman Co., Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1988
Decision
108d
Days
Class 2
Risk

K880963 is an FDA 510(k) clearance for the HAC AUTOLOGY CENTERS DISPENSING KIT FOR FIB.CON.. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Buckman Co., Inc. (Martinez, US). The FDA issued a Cleared decision on June 24, 1988 after a review of 108 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 Buckman Co., Inc. devices

Submission Details

510(k) Number K880963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1988
Decision Date June 24, 1988
Days to Decision 108 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
21d faster than avg
Panel avg: 129d · This submission: 108d
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 223
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K880963.
DISPENSING PIN/CHEMOTHERAPY DISPENSING PIN
K890082 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1989
SINGLE-FIL(TM) SYRINGE
K883955 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1988
BD MICROFINE IV PEN INJECTOR
K881775 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1988
DISPOSABLE SYRINGE
K882335 · Baxter Healthcare Corp · Jun 1988
SAFETY SYRINGE
K872820 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1987
MONOJECT PHARMACY TRAY
K860688 · Sherwood Medical Co. · Aug 1987