510(k) Report

510(k) · Cleared

Cleared

Oxygen Regulators #50 PRT & BGT (BGT15,BGT18

K852374510(k) TraditionalCleared Jul 12, 198538-day reviewClass I21 CFR 868.2700

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

The Timeter Group · CAN Regulator, Pressure, Gas Cylinder

Cleared on Jul 12, 1985 after a 38-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jul 12, 1985
Review
38 days
Class
Class I
Product code
CAN
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K852374Source: 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 CAN? 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 CAN devices

CAN Regulator, Pressure, Gas Cylinder: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CAN

1in 2017

2009: 12017: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CAN

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

Recalls per year · CAN

3in 2021

2009: 52012: 1, 1 Class I2015: 12021: 3
2007high 5 (2009) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · CAN

3in 2025

2007: 22008: 82009: 52010: 72011: 52012: 232013: 62014: 122015: 122016: 132017: 112018: 2382019: 202020: 22021: 62022: 62023: 192024: 592025: 3
2007high 238 (2018) · low 2 (2007)2025

MAUDE reports naming product code CAN, 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—08
20091—55
20100—07
20110—05
20120—1 (1)23
20130—06
20140—012
20150—112
20160—013
20171—011
20180—0238
20190—020
20200—02
20210—36
20220—06
20230—019
20240—059
20250—03
20260—0—

More from The Timeter Group

4 FDA decisions under this applicant name. See the company

  • K871452Classic (TM) 200 Oxygen FlowmeterThe Timeter Group · 1987
  • K862171MP-500 Electronic NebulizerThe Timeter Group · 1986
  • K844556KHM 2000 Drip WatcherThe Timeter Group · 1985

Recent decisions in CAN

The CAN category page

  • K162811MR Conditional CGA 870Essex Industries, Inc. · 2017
  • K080243Portable Oxygen Unit SCA900San Cheong Co., Ltd. · 2009
  • K060265Remcore Remote Controlled Oxygen RegulatorRemcore, Inc. · 2006
  • K061785Cyl-Fil Oxygen SystemResponsive Respiratory, Inc. · 2006
  • K950777Oxygen RegulatorMada Medical Products, Inc. · 1995

https://510kreport.com/device/K852374 · printed Nov 4, 2026

Cite this page

510(k) Report. “K852374: Oxygen Regulators #50 PRT & BGT (BGT15,BGT18.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K852374

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