Cleared Traditional

K252318 - Insufflator (OPTO-IFL1000) (FDA 510(k) Clearance)

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

K252318 · Guangdong Optomedic Technologies, Inc. · Obstetrics & Gynecology device
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Apr 2026
Decision
265d
Days
Class 2
Risk

K252318 is an FDA 510(k) clearance for the Insufflator (OPTO-IFL1000). Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Guangdong Optomedic Technologies, Inc. (Foshan, CN). The FDA issued a Cleared decision on April 16, 2026 after a review of 265 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 Guangdong Optomedic Technologies, Inc. devices

Submission Details

510(k) Number K252318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2025
Decision Date April 16, 2026
Days to Decision 265 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
105d slower than avg
Panel avg: 160d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Peers - HIF Insufflator, Laparoscopic

All 176
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K252318.
ENDOFLATOR +
K250388 · Karl Storz SE & CO. KG · Sep 2025
AirSurgN Insufflator (10030/AirSurgN)
K242772 · Smartsurgn, Inc. · Apr 2025
High Flow Insufflation Unit (UHI-4)
K243527 · Olympus Medical Systems Corporation · Jan 2025
TauTona Pneumoperitoneum Assist Device (TPAD)
K242536 · Tautona Group · Oct 2024
VereSee Optical Veres Needle System
K232464 · Freyja Healthcare, LLC · May 2024
EVA15 insufflator
K232902 · Palliare , Ltd. · May 2024