510(k) Report

510(k) · Cleared

Cleared

Anaerobic Carbon Dioxide

K822752510(k) TraditionalCleared Oct 22, 198239-day reviewClass I21 CFR 868.6400

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

Liquid Carbonic Corp. · BXK Gas, Calibration (Specified Concentration)

Cleared on Oct 22, 1982 after a 39-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Oct 22, 1982
Review
39 days
Class
Class I
Product code
BXK
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K822752Source: 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 BXK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • 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?

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 BXK devices

BXK Gas, Calibration (Specified Concentration): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BXK

FDA has decided no BXK device since 2007.

Median 510(k) review, days · BXK

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

Recalls per year · BXK

No recall names BXK since 2007.

Adverse event reports per year · BXK

2in 2025

2010: 12019: 12025: 2
2007high 2 (2025) · low 0 (2007)2025

MAUDE reports naming product code BXK, 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—00
20080—00
20090—00
20100—01
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—01
20200—00
20210—00
20220—00
20230—00
20240—00
20250—02
20260—0—
Cite this page

510(k) Report. “K822752: Anaerobic Carbon Dioxide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K822752

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