Cleared Traditional

K862116 - STOCKERT-SHILEY DOUBLE HEAD PUMP MODULE

K862116 is an FDA 510(k) clearance for STOCKERT-SHILEY DOUBLE HEAD PUMP MODULE, manufactured by Shiley, Inc.. The device is a Class 2 Cardiovascular device with product code DWB cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K862116 · Shiley, Inc. · Cardiovascular device
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Jul 1986
Decision
43d
Days
Class 2
Risk

K862116 is an FDA 510(k) clearance for the STOCKERT-SHILEY DOUBLE HEAD PUMP MODULE. Classified as Pump, Blood, Cardiopulmonary Bypass, Roller Type (product code DWB), Class II - Special Controls.

Submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on July 16, 1986 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4370 - 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 - K862116

510(k) Number K862116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1986
Decision Date July 16, 1986
Days to Decision 43 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
82d faster than avg
Panel avg: 125d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWB Device Classification - Class 2, Special Controls

Product Code DWB Pump, Blood, Cardiopulmonary Bypass, Roller Type
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4370
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 - DWB Pump, Blood, Cardiopulmonary Bypass, Roller Type

All 14
Devices cleared under the same product code (DWB) and FDA review panel - the closest regulatory comparables to K862116.
MODIFIED STOCKERT-SHILEY CAPS MULTI. ROLLER PUMP
K890904 · Shiley, Inc. · Apr 1989
ANGIOMED INTRODUCING SETS
K874771 · Angiomed U.S., Inc. · Jan 1988
STOCKERT-SHILEY MULTIFLOW ROLLER PUMP MODULE
K861714 · Shiley, Inc. · Jul 1986
CARDIOPLEGIA RECIRCULATION SYS-BL 705/A
K831458 · Electromedics, Inc. · Oct 1983
SARNS PULSATILE PUMP
K820729 · 3M Health Care, Sarns · Nov 1982
PUMP MODULES PMO LO-110-PMD 10-210
K822071 · Gambro, Inc. · Aug 1982