Cleared Traditional

HEAL FORCE CO2 INCUBATOR (K101988) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K101988 · Shanghai Lishen Scientific Equipment Co., Ltd. · Obstetrics & Gynecology device
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Feb 2011
Decision
209d
Days
Class 2
Risk

K101988 is an FDA 510(k) clearance for the HEAL FORCE CO2 INCUBATOR. Classified as Accessory, Assisted Reproduction (product code MQG), Class II - Special Controls.

Submitted by Shanghai Lishen Scientific Equipment Co., Ltd. (Echo, US). The FDA issued a Cleared decision on February 8, 2011 after a review of 209 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6120 - the FDA obstetrics and gynecology device 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 Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Shanghai Lishen Scientific Equipment Co., Ltd. devices

Submission Details

510(k) Number K101988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2010
Decision Date February 08, 2011
Days to Decision 209 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 160d · This submission: 209d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQG Accessory, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6120
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - MQG Accessory, Assisted Reproduction

All 45
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