Cleared Traditional

K223625 - CapnoSpot Pneumothorax Decompression In...

K223625 is an FDA 510(k) clearance for CapnoSpot Pneumothorax Decompression In..., manufactured by Pneumeric, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GAA cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K223625 · Pneumeric, Inc. · General & Plastic Surgery device
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Mar 2023
Decision
113d
Days
Class 1
Risk

K223625 is an FDA 510(k) clearance for the CapnoSpot™ Pneumothorax Decompression Indicator. Classified as Needle, Aspiration And Injection, Disposable (product code GAA), Class I - General Controls.

Submitted by Pneumeric, Inc. (Rochester, US). The FDA issued a Cleared decision on March 28, 2023 after a review of 113 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Pneumeric, Inc. devices

FDA 510(k) Submission Details - K223625

510(k) Number K223625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2022
Decision Date March 28, 2023
Days to Decision 113 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 115d · This submission: 113d
Pathway characteristics
Predicate-based equivalence.

GAA Device Classification - Class 1, General Controls

Product Code GAA Needle, Aspiration And Injection, Disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GAA Needle, Aspiration And Injection, Disposable

All 47
Devices cleared under the same product code (GAA) and FDA review panel - the closest regulatory comparables to K223625.
MANAN ACCURA NEEDLE
K974741 · Medical Device Technologies, Inc. · Jan 1998
BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4)
K962425 · Radi Medical Systems AB · Sep 1996
MD TECH BIOPSY SET FOR BONE AND BONE MARROW
K961959 · Medical Device Technologies, Inc. · Jul 1996
MONOJECT BONE MARROW BIOPSY TRAYS
K945109 · Sherwood Medical Co. · Nov 1994
MANAN GENERAL PURPOSE INTRODUCER NEEDLE
K940024 · Manan Medical Products, Inc. · Feb 1994
MANAN BONE MARROW HARVEST NEEDLES
K940025 · Manan Medical Products, Inc. · Feb 1994