Insufflator (OPTO-IFL1000)— 510(k) K252318

Name: FDA 510(k) clearance K252318
Creator: U.S. Food and Drug Administration
Published: 2026-04-16

Substantially Equivalent

Guangdong Optomedic Technologies, Inc.

FDA 510(k) clearance K252318 for Insufflator (OPTO-IFL1000), Substantially Equivalent on 2026-04-16. Applicant: Guangdong Optomedic Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Guangdong Optomedic Technologies, Inc.
Product code: Code HIF
Device class: Class 2
Regulation: 21 CFR 884.1730
Advisory panel: Obstetrics/Gynecology
Date received: 2025-07-25
Decision date: 2026-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Foshan, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code HIF

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K260209 — ENDOFLATOR+; Smart Smoke Evacuation2026-08-19
K252584 — Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)2026-06-25
K250388 — ENDOFLATOR +2025-09-22
K242772 — AirSurgN Insufflator (10030/AirSurgN)2025-04-11
K243527 — High Flow Insufflation Unit (UHI-4)2025-01-13

More clearances from Guangdong Optomedic Technologies, Inc.

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K252697 — 3D Laparoscope2025-10-29
K242513 — FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K)2024-10-23
K241530 — Stellar Imaging System2024-08-07
K231342 — Insufflator (OPTO-IFL1000)2023-09-20
K230407 — FloNavi Open Field Fluorescence Imaging System2023-07-17

Adverse events under product code HIF

product code HIF

Death: 19
Injury: 578
Malfunction: 5,639
Total: 6,236

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.