Cleared Traditional

K861607 - SCHNEIDER-SHILEY INFLATION SYRINGES

K861607 is an FDA 510(k) clearance for SCHNEIDER-SHILEY INFLATION SYRINGES, manufactured by Shiley, Inc.. The device is a Class 2 Cardiovascular device with product code MAV cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K861607 · Shiley, Inc. · Cardiovascular device
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Jun 1986
Decision
41d
Days
Class 2
Risk

K861607 is an FDA 510(k) clearance for the SCHNEIDER-SHILEY INFLATION SYRINGES. Classified as Syringe, Balloon Inflation (product code MAV), Class II - Special Controls.

Submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on June 9, 1986 after a review of 41 days - a notably fast clearance cycle.

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: 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 Shiley, Inc. devices

FDA 510(k) Submission Details - K861607

510(k) Number K861607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1986
Decision Date June 09, 1986
Days to Decision 41 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 125d · This submission: 41d
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 32
Devices cleared under the same product code (MAV) and FDA review panel - the closest regulatory comparables to K861607.
CATHETER BALLOON DILATOR PRESSURE GAUGE
K895511 · Argon Medical Corp. · Feb 1990
ACS INDEFLATOR XX
K896849 · Advanced Cardiovascular Systems, Inc. · Feb 1990
INFLATION PRO II
K895836 · Baxter Healthcare Corp · Dec 1989
SCIMED PM200 INFLATION MANOMETER
K843448 · Scimed Life Systems, Inc. · Oct 1984
EDSLAB PRESSURE GAUGE
K832323 · American Edwards Laboratories · Aug 1983