510(k) Report

510(k) · Cleared

Cleared

CO/CMD-1

K900322510(k) TraditionalCleared Apr 30, 199097-day reviewClass II21 CFR 868.1430

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

Spirometrics, Inc. · CCJ Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase

Cleared on Apr 30, 1990 after a 97-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Apr 30, 1990
Review
97 days
Class
Class II
Product code
CCJ
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K900322Source: FDA 510(k) database · 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in CCJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new CCJ device

  1. #1 K253119 CoSense ETCO Monitorscore 12.6 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

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.

How does its category compare?

All CCJ devices

CCJ Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CCJ

2in 2021

2008: 22010: 12012: 12014: 12015: 12017: 12018: 12019: 12021: 22026 (partial year): 1
2007high 2 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CCJ

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

Recalls per year · CCJ

No recall names CCJ since 2007.

Adverse event reports per year · CCJ

No MAUDE report names CCJ since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20082—00
20090—00
20101—00
20110—00
20121—00
20130—00
20141—00
20151—00
20160—00
20171—00
20181—00
20191—00
20200—00
20212—00
20220—00
20230—00
20240—00
20250—00
20261—0—

More from Spirometrics, Inc.

11 FDA decisions under this applicant name. See the company

  • K915059Peak Flow MonitorSpirometrics, Inc. · 1992
  • K911358CMD/Dlco Diagnostic SpirometerSpirometrics, Inc. · 1991
  • K900673Serial FlowSpirometrics, Inc. · 1990
  • K901057Spirometrics Model 2600 Miro SpirometerSpirometrics, Inc. · 1990
  • K884464Spirometrics Model 2200 SM200 Flow SensorSpirometrics, Inc. · 1989

Recent decisions in CCJ

The CCJ category page

  • K253119CoSense ETCO MonitorCapnia, Inc. · 2026
  • K211918iCOquit® Smokerlyzer®Bedfont Scientific, Ltd. · 2021
  • K201206Pivot Breath SensorCarrot, Inc. · 2021
  • K173238ToxCOBedfont Scientific, Ltd. · 2019
  • K171129CO Check Pro, CO ScreenMD Diagnostics Limited · 2018

https://510kreport.com/device/K900322 · printed Nov 5, 2026

Cite this page

510(k) Report. “K900322: CO/CMD-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K900322

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026