Cleared Traditional

GUARDIAN 110, VOL. CONTROL DELIV. SYS (K823406) - FDA 510(k) Clearance

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

K823406 · Avi, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1982
Decision
37d
Days
Class 2
Risk

K823406 is an FDA 510(k) clearance for the GUARDIAN 110, VOL. CONTROL DELIV. SYS. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Avi, Inc.. The FDA issued a Cleared decision on December 22, 1982 after a review of 37 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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 Avi, Inc. devices

Submission Details

510(k) Number K823406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1982
Decision Date December 22, 1982
Days to Decision 37 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
92d faster than avg
Panel avg: 129d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 - FRN Pump, Infusion

All 235
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K823406.
EXTERNAL INFUSION PUMP
K830151 · Intermedics, Inc. · Feb 1983
HARVARD APPARATUS FAMILY OF FLUID INFUS
K830177 · C.R. Bard, Inc. · Feb 1983
VOLUMETRIC PUMP ADMIN. SETS
K830017 · Travenol Laboratories, S.A. · Jan 1983
FLO-GARD 2000 ENTERNAL PUMP & TRAVASORB
K823063 · Travenol Laboratories, S.A. · Nov 1982
HARVARD APPARATUS SINGLE SPEED SYRINGE
K822989 · C.R. Bard, Inc. · Nov 1982
FLEXIFLO-II
K821661 · Abbott Laboratories · Jun 1982