Cleared Traditional

K832350 - INTRABIONIC CO. - MICRO SYRINGE

K832350 is an FDA 510(k) clearance for INTRABIONIC CO. - MICRO SYRINGE, manufactured by Intrabionic Co.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K832350 · Intrabionic Co. · General Hospital
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Nov 1983
Decision
133d
Days
Class 2
Risk

K832350 is an FDA 510(k) clearance for the INTRABIONIC CO. - MICRO SYRINGE. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Intrabionic Co. (Mchenry, US). The FDA issued a Cleared decision on November 28, 1983 after a review of 133 days - within the typical 510(k) review window.

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: 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 Intrabionic Co. devices

FDA 510(k) Submission Details - K832350

510(k) Number K832350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1983
Decision Date November 28, 1983
Days to Decision 133 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
4d slower than avg
Panel avg: 129d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

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 621
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K832350.
GILLETTE SABRE SYRINGE
K833655 · Intermedics, Inc. · Dec 1983
FLO-GARD 8100 INFUSION PUMP
K833958 · Travenol Laboratories, S.A. · Dec 1983
VOLUMETRIC PUMP SET 2C9100 FOR NITROGLY
K832285 · Travenol Laboratories, S.A. · Dec 1983
BETATRON I AMBULATORY INSULIN PUMP
K833306 · Cardiac Pacemakers, Inc. · Nov 1983
ACCU-RYNGE PUMP SP-250
K830389 · Delta Medical Industries · Sep 1983
SINGLE USE SYRINGE #103 PERSONAL MEDIC
K831444 · Pacesetter Systems · Sep 1983