Cleared Traditional

K881006 - STOCKERT-SHILEY BUBBLE MONITOR 23-23-01

K881006 is an FDA 510(k) clearance for STOCKERT-SHILEY BUBBLE MONITOR 23-23-01, manufactured by Shiley, Inc.. The device is a Class 2 Cardiovascular device with product code DRY cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K881006 · Shiley, Inc. · Cardiovascular device
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May 1988
Decision
76d
Days
Class 2
Risk

K881006 is an FDA 510(k) clearance for the STOCKERT-SHILEY BUBBLE MONITOR 23-23-01. Classified as Monitor, Blood-gas, On-line, Cardiopulmonary Bypass (product code DRY), Class II - Special Controls.

Submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on May 24, 1988 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4330 - 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 - K881006

510(k) Number K881006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1988
Decision Date May 24, 1988
Days to Decision 76 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
49d faster than avg
Panel avg: 125d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRY Device Classification - Class 2, Special Controls

Product Code DRY Monitor, Blood-gas, On-line, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4330
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 - DRY Monitor, Blood-gas, On-line, Cardiopulmonary Bypass

All 21
Devices cleared under the same product code (DRY) and FDA review panel - the closest regulatory comparables to K881006.
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