510(k) Report

510(k) · Cleared

Recalled · Class II · 2015

Precision Medical Oxygen Regulator

K901831510(k) TraditionalCleared Aug 14, 1990112-day reviewClass I21 CFR 868.2700Recalls 1

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

Precision Medical, Inc. · CAN Regulator, Pressure, Gas Cylinder

Cleared on Aug 14, 1990 after a 112-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it. It has been recalled once.

Decided
Aug 14, 1990
Review
112 days
Class
Class I
Product code
CAN
Recalls
1
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2009: 1 descendant cleared1990200020102020
  1. This deviceK901831 Precision Medical Oxygen RegulatorPrecision Medical, Inc. · 1990
  2. Descendant · cites it directly · 1 of its ownK061785 Cyl-Fil Oxygen SystemResponsive Respiratory, Inc. · 2006
  3. Descendant · 2 generations on · 0 of its ownK080243 Portable Oxygen Unit SCA900San Cheong Co., Ltd. · 2009

Most influential descendants

Showing 2 of 2 · See all
  • K061785Cyl-Fil Oxygen SystemResponsive Respiratory, Inc. · 2006 · cites it directly1descendant
  • K080243Portable Oxygen Unit SCA900San Cheong Co., Ltd. · 2009 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K901831Precision Medical Oxygen RegulatorPrecision Medical, Inc.1990—
+1K061785Cyl-Fil Oxygen SystemResponsive Respiratory, Inc.2006—
+2K080243Portable Oxygen Unit SCA900San Cheong Co., Ltd.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200910
FIG. 1 — Lineage of K901831, 1990–2009Source: 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), 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? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K061785Cyl-Fil Oxygen SystemResponsive Respiratory, Inc.20061

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

Recalls of this device

DateClassRecallRoot causeReason
Oct 8, 2015Class IIZ-0272-2016Error in labelingThese lots of Oxygen Dial Regulators could have the settings label off by one position. When the indicator arrow points to OFF position, the regulator is actually on the half liter setting (0.50), for the 15 liter. For the 8 liter…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K061785 (Responsive Respiratory, Inc., 2006) has gone furthest, with 1 descendant of its own.

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 Precision Medical, Inc.

30 FDA decisions under this applicant name. See the company

  • K173807Accu O2 Oxygen AnalyzerPrecision Medical, Inc. · 2018
  • K140179Easy GO VacPrecision Medical, Inc. · 2014
  • K103563Precision Portable Oxygen Concentration Model 4150Precision Medical, Inc. · 2011
  • K103324Precision Liquid Oxygen SystemPrecision Medical, Inc. · 2011
  • K090781HELIO2 BlenderPrecision Medical, Inc. · 2009

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/K901831 · printed Nov 6, 2026

Cite this page

510(k) Report. “K901831: Precision Medical Oxygen Regulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K901831

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