Cleared Traditional

K853136 - MODEL 1100 APC(ANGIOPLASTY PRESSURE CONTROLLER)

K853136 is an FDA 510(k) clearance for MODEL 1100 APC(ANGIOPLASTY PRESSURE CON..., manufactured by E.A. Fischione Instrument Mfg.. The device is a Class 2 Cardiovascular device with product code MAV cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K853136 · E.A. Fischione Instrument Mfg. · Cardiovascular device
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Dec 1985
Decision
130d
Days
Class 2
Risk

K853136 is an FDA 510(k) clearance for the MODEL 1100 APC(ANGIOPLASTY PRESSURE CONTROLLER). Classified as Syringe, Balloon Inflation (product code MAV), Class II - Special Controls.

Submitted by E.A. Fischione Instrument Mfg. (Pittsburgh, US). The FDA issued a Cleared decision on December 3, 1985 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all E.A. Fischione Instrument Mfg. devices

FDA 510(k) Submission Details - K853136

510(k) Number K853136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1985
Decision Date December 03, 1985
Days to Decision 130 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 125d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MAV Device Classification - Class 2, Special Controls

Product Code MAV Syringe, Balloon Inflation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - MAV Syringe, Balloon Inflation

All 50
Devices cleared under the same product code (MAV) and FDA review panel - the closest regulatory comparables to K853136.
ACS INDEFLATOR XX
K896849 · Advanced Cardiovascular Systems, Inc. · Feb 1990
INFLATION PRO II
K895836 · Baxter Healthcare Corp · Dec 1989
SCHNEIDER-SHILEY INFLATION SYRINGES
K861607 · Shiley, Inc. · Jun 1986
SCIMED PM200 INFLATION MANOMETER
K843448 · Scimed Life Systems, Inc. · Oct 1984
EDSLAB PRESSURE GAUGE
K832323 · American Edwards Laboratories · Aug 1983