Cleared Traditional

K222812 - Insufflator

K222812 is an FDA 510(k) clearance for Insufflator, manufactured by Scivita Medical Technology Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HIF cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K222812 · Scivita Medical Technology Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2023
Decision
239d
Days
Class 2
Risk

K222812 is an FDA 510(k) clearance for the Insufflator. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Scivita Medical Technology Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on May 16, 2023 after a review of 239 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1730 - 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 Scivita Medical Technology Co., Ltd. devices

FDA 510(k) Submission Details - K222812

510(k) Number K222812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2022
Decision Date May 16, 2023
Days to Decision 239 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 160d · This submission: 239d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIF Device Classification - Class 2, Special Controls

Product Code HIF Insufflator, Laparoscopic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1730
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 Consultant

Mid-Link Consulting Co, Ltd.
Diana Hong

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HIF Insufflator, Laparoscopic

All 91
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K222812.
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Gas Insufflator
K221995 · Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · Mar 2023
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K212786 · Core Access Surgical Technologies, Inc. · Feb 2022