Cleared Traditional

K952566 - OSCILFLATOR

K952566 is the FDA 510(k) clearance for OSCILFLATOR by Surgical Technologies, Inc.. It is a Class 2 Cardiovascular device (product code MAV) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K952566 · Surgical Technologies, Inc. · Cardiovascular device
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Aug 1995
Decision
90d
Days
Class 2
Risk

K952566 is an FDA 510(k) clearance for the OSCILFLATOR. Classified as Syringe, Balloon Inflation (product code MAV), Class II - Special Controls.

Submitted by Surgical Technologies, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on August 31, 1995 after a review of 90 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 Surgical Technologies, Inc. devices

Submission Details

510(k) Number K952566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1995
Decision Date August 31, 1995
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 31
Devices cleared under the same product code (MAV) and FDA review panel - the closest regulatory comparables to K952566.
INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE)
K962495 · Advanced Cardiovascular Systems, Inc. · Sep 1996
INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE)
K961471 · Advanced Cardiovascular Systems, Inc. · May 1996
SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE
K955869 · Scimed Life Systems, Inc. · Mar 1996
MONARCH AP(TM)
K943597 · Merit Medical Systems, Inc. · Feb 1995
MEDFLATOR II(TM) DISPOSABLE INFLATION DEVICE
K940896 · Medex, Inc. · Aug 1994
10 AND 20 CC INFLATION/DEFLATION DEVICES W/GAUGE
K922573 · Boston Scientific Corp · Dec 1992