510(k) Report

510(k) · Cleared

Cleared

CapnoSpot™ Pneumothorax Decompression Indicator

K223625510(k) TraditionalCleared Mar 28, 2023113-day reviewClass I21 CFR 878.4800

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Pneumeric, Inc. · GAA Needle, Aspiration And Injection, Disposable

Cleared on Mar 28, 2023 as substantially equivalent to K923028 (Symbiosis Corp., 1992) after a 113-day review. Its family tree reaches back 1 generation to 1992.

Decided
Mar 28, 2023
Review
113 days
Class
Class I
Product code
GAA
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K923028 (1992). No later device cites it as a predicate yet.

K923028 · Turkel Pneumothorax Kit · Symbiosis Corp. · 199219901995200020052010201520202025
K923028 · Turkel Pneumothorax Kit · Symbiosis Corp. · 19920
  1. Root · 1 generation backK923028 Turkel Pneumothorax KitSymbiosis Corp. · 1992
  2. This deviceK223625 CapnoSpot™ Pneumothorax Decompression IndicatorPneumeric, Inc. · 2023
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K923028Turkel Pneumothorax KitSymbiosis Corp.1992—
0 (this device)K223625CapnoSpot™ Pneumothorax Decompression IndicatorPneumeric, Inc.2023—
FIG. 1 — Lineage of K223625, 1992–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K923028Turkel Pneumothorax Kit
Summary page 5
…PREDICATE DEVICE The Pneumeric CapnoSpot Pneumothorax Decompression Indicator (“CapnoSpot” or “device”) is substantially equivalent to the Turkel Pneumothorax Kit (K923028). DEVICE DESCRIPTION The Pneumeric Capnospot Pneumothorax Decompression Indicator is a capnography device that provides…
Symbiosis Corp.1992—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.

How does its category compare?

All GAA devices

GAA Needle, Aspiration And Injection, Disposable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · GAA

1in 2023

2011: 12023: 1
2007high 1 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GAA

Too few GAA 510(k)s in any year since 2007 to give a median.

Recalls per year · GAA

2in 2022

2008: 12009: 22010: 22019: 102021: 52022: 2
2007high 10 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GAA

348in 2025

2007: 122008: 322009: 202010: 182011: 92012: 242013: 332014: 242015: 322016: 452017: 852018: 1222019: 1532020: 1022021: 1082022: 742023: 1182024: 1812025: 348
2007high 348 (2025) · low 9 (2011)2025

MAUDE reports naming product code GAA, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—012
20080—132
20090—220
20100—218
20111—09
20120—024
20130—033
20140—024
20150—032
20160—045
20170—085
20180—0122
20190—10153
20200—0102
20210—5108
20220—274
20231—0118
20240—0181
20250—0348
20260—0—

What is it indicated for?

Used for more accurate placement of pneumothorax decompression devices than the current standard of care

auditory assessments. The Pneumothorax Decompression Indicator is a colorimetric capnography device

indicated to detect the carbon dioxide in the gas passing through the device used to treat pneumothorax with

suspected tension physiology.

Indications for use as stated in the FDA summary.

Recent decisions in GAA

The GAA category page

  • K102274Arvik Laparoscopic Aspiration InstrumentArvik Enterprises/ Mini Lap Technologies · 2011
  • K011586Irma SL Blood Analysis System GL CartridgeDiametrics Medical, Inc. · 2001
  • K994151Percutx-Injection/Aspiration Needle Probes/DevicesXimed/Prosure/Injectx · 2000
  • K983200Injection/Aspiration Needles Probes/Devices-Tpi/Tpi FlexXimed/Prosure/Injectx · 1998
  • K974741Manan Accura NeedleMedical Device Technologies, Inc. · 19981 recall

https://510kreport.com/device/K223625 · printed Nov 6, 2026

Cite this page

510(k) Report. “K223625: CapnoSpot™ Pneumothorax Decompression Indicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223625

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026