510(k) Report

510(k) · Cleared

Cleared

Baralyme CO2 Absorbent

K811260510(k) TraditionalCleared May 27, 198121-day reviewClass I21 CFR 868.5300

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

Allied Healthcare Products, Inc. · CBL Absorbent, Carbon-Dioxide

Cleared on May 27, 1981 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
May 27, 1981
Review
21 days
Class
Class I
Product code
CBL
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K811260Source: 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 CBL? 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 CBL devices

CBL Absorbent, Carbon-Dioxide: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CBL

FDA has decided no CBL device since 2007.

Median 510(k) review, days · CBL

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

Recalls per year · CBL

3in 2010

2010: 3
2007high 3 (2010) · low 0 (2007)2026

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

Adverse event reports per year · CBL

17in 2025

2007: 22008: 32009: 22010: 82011: 22012: 12013: 12015: 22016: 42018: 42019: 42020: 102021: 222022: 202023: 92024: 62025: 17
2007high 22 (2021) · low 0 (2014)2025

MAUDE reports naming product code CBL, 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—02
20080—03
20090—02
20100—38
20110—02
20120—01
20130—01
20140—00
20150—02
20160—04
20170—00
20180—04
20190—04
20200—010
20210—022
20220—020
20230—09
20240—06
20250—017
20260—0—

More from Allied Healthcare Products, Inc.

26 FDA decisions under this applicant name. See the company

  • K131098Emergency Portable VentilatorAllied Healthcare Products, Inc. · 2014
  • K132021Ahp 300, Emergency Portable VentilatorAllied Healthcare Products, Inc. · 2014
  • K090356Emergency Portable Ventilator, Model EPV200Allied Healthcare Products, Inc. · 2009
  • K083507Battery Pack for MCV100 and MCV200 Emergency VentilatorsAllied Healthcare Products, Inc. · 2009
  • K083385Mass Casualty Ventilators, Models: MCV200 and MCV200-BAllied Healthcare Products, Inc. · 2009

Recent decisions in CBL

The CBL category page

  • K921803Sofnolime Carbon Dioxide AbsorbentMolecular Products, Ltd. · 1992
  • K897171Disposable CO2 Absorber/EGibeck, Inc. · 1990
  • K860147Carbon Dioxide AbsorbentsDentsply Intl. · 1986
  • K853571Medipart Soda Lime MP-3522Medipart Jerry Alexander · 1985

https://510kreport.com/device/K811260 · printed Nov 4, 2026

Cite this page

510(k) Report. “K811260: Baralyme CO2 Absorbent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K811260

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