Cleared Traditional

K112975 - CARBONAID C02 DIFFUSER

K112975 is an FDA 510(k) clearance for CARBONAID C02 DIFFUSER, manufactured by Cardia Innovation AB. The device is a Class 2 Obstetrics & Gynecology device with product code HIF cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K112975 · Cardia Innovation AB · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
261d
Days
Class 2
Risk

K112975 is an FDA 510(k) clearance for the CARBONAID C02 DIFFUSER. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Cardia Innovation AB (Edina, US). The FDA issued a Cleared decision on June 22, 2012 after a review of 261 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.

FDA 510(k) Submission Details - K112975

510(k) Number K112975 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2011
Decision Date June 22, 2012
Days to Decision 261 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
100d slower than avg
Panel avg: 161d · This submission: 261d
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 Peers - HIF Insufflator, Laparoscopic

All 178
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K112975.
NEBULAE I
K120151 · Northgate Technologies, Inc. · Aug 2012
INSUFLOW SYNERGY PORT
K120640 · Lexion Medical, LLC · Jul 2012
MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000
K121336 · Surgiquest, Inc. · Jul 2012
HIGH FLOW INSUFFLATION UNIT UHI-4
K110294 · Olympus Medical Systems Corporation · Nov 2011
MEDLINE PNEUMOPERITONEUM NEEDLE
K111955 · Medline Industries, Inc. · Nov 2011
VESSEL GUARDIAN
K112357 · Lexion Medical, LLC · Nov 2011
K112975 · CARBONAID C02 DIFFUSER
Download PDF FDA Summary Cardia Innovation AB