510(k) Report

510(k) · Cleared

Cleared

Cyl-Fil Oxygen System

K061785510(k) TraditionalCleared Sep 7, 200676-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

Responsive Respiratory, Inc. · CAN Regulator, Pressure, Gas Cylinder

Cleared on Sep 7, 2006 as substantially equivalent to K031983 (Inovo, Inc., 2003) and 4 other predicates after a 76-day review. Its family tree reaches back 3 generations to 1996. 1 later device descends from it.

Decided
Sep 7, 2006
Review
76 days
Class
Class I
Product code
CAN
Recalls
None
Predicates
5

Its longest line of descent runs back 3 generations to K963247 (1996). 8 ancestors in all, the oldest K780359 (1978). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor1990: 1 other ancestor1989: 1 other ancestor1978: 1 other ancestor2001: 1 other ancestor2009: 1 descendant clearedK963247 · Victor Model Ocpr Oxygen Conserving Pressure Regulator · Thermadyne Holings Corp. · 1996K992659 · O2N Demand-II, Victor Model Ocpr-II · Thermadyne Holings Corp. · 1999K031983 · Inovo, Inc, Economizer Conserving Regulator · Inovo, Inc. · 200319801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 1 other ancestor 1 generation forward: 1 descendant K031983 · Inovo, Inc, Economizer Conserving Regulator · Inovo, Inc. · 2003K992659 · O2N Demand-II, Victor Model Ocpr-II · Thermadyne Holings Corp. · 1999K963247 · Victor Model Ocpr Oxygen Conserving Pressure Regulator · Thermadyne Holings Corp. · 19960
  1. Root · 3 generations backK963247 Victor Model Ocpr Oxygen Conserving Pressure RegulatorThermadyne Holings Corp. · 1996
  2. 2 generations backK992659 O2N Demand-II, Victor Model Ocpr-IIThermadyne Holings Corp. · 1999
  3. 1 generation backK031983 Inovo, Inc, Economizer Conserving RegulatorInovo, Inc. · 2003
  4. This deviceK061785 Cyl-Fil Oxygen SystemResponsive Respiratory, Inc. · 2006
  5. Descendant · cites it directly · 0 of its ownK080243 Portable Oxygen Unit SCA900San Cheong Co., Ltd. · 2009

Most influential descendants

Showing 1 of 1 · See all
  • K080243Portable Oxygen Unit SCA900San Cheong Co., Ltd. · 2009 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K963247Victor Model Ocpr Oxygen Conserving Pressure RegulatorThermadyne Holings Corp.1996—
−2K992659O2N Demand-II, Victor Model Ocpr-IIThermadyne Holings Corp.1999—
−1K031983Inovo, Inc, Economizer Conserving RegulatorInovo, Inc.2003—
0 (this device)K061785Cyl-Fil Oxygen SystemResponsive Respiratory, Inc.2006—
+1K080243Portable Oxygen Unit SCA900San Cheong Co., Ltd.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198910
199010
199510
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
FIG. 1 — Lineage of K061785, 1996–2009Source: 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), the FDA summary (predicates and indications), 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? (7)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K031983Inovo, Inc, Economizer Conserving Regulator
Summary page 1
…: Class 1, 21CFR 868.2700 73 CAN 3. Predicate Device Information: Regulators & Conservinq Regulators Inovo Inc.- Oxygen Conserving Regulator #K031983 Same components, material and design as Cyl-Fil regulator. Victor Equipment (Thermadyne) - K891771 (6-…
Inovo, Inc.2003—
*K891771Victor Medical Oxygen Therapy Regulator, Modified
Summary page 1
…Inovo Inc.- Oxygen Conserving Regulator #K031983 Same components, material and design as Cyl-Fil regulator. Victor Equipment (Thermadyne) - K891771 (6-23-1989) MADA Medical - K950777 (4-14-1995) Erie Medical - K780359 (4-4-1978) Precision Medic…
Thermadyne Holings Corp.1989—
*K950777Oxygen Regulator
Summary page 2
…Same components, material and design as Cyl-Fil regulator. Victor Equipment (Thermadyne) - K891771 (6-23-1989) MADA Medical - K950777 (4-14-1995) Erie Medical - K780359 (4-4-1978) Precision Medical - K901831 (8-14-1990) Oxygen Cylinder Valve -…
Mada Medical Products, Inc.1995—
*K780359Oxygen Regulator/Flowmeter
Summary page 2
…l and design as Cyl-Fil regulator. Victor Equipment (Thermadyne) - K891771 (6-23-1989) MADA Medical - K950777 (4-14-1995) Erie Medical - K780359 (4-4-1978) Precision Medical - K901831 (8-14-1990) Oxygen Cylinder Valve - Class 1 (unclassified) - Product Code ECX…
Erie Mfg., Co.1978—
*K901831Precision Medical Oxygen Regulator
Summary page 2
…or Equipment (Thermadyne) - K891771 (6-23-1989) MADA Medical - K950777 (4-14-1995) Erie Medical - K780359 (4-4-1978) Precision Medical - K901831 (8-14-1990) Oxygen Cylinder Valve - Class 1 (unclassified) - Product Code ECX Cavagna Group - 1.…
Precision Medical, Inc.19901
*—Sherwood Valve Co. a division of Harsco Corp.
Named without a submission number
—
*—Cavagna Group
Named without a submission number
—

Also cleared against K031983: 2 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K080243Portable Oxygen Unit SCA900San Cheong Co., Ltd.20090

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.

What does this lineage say?

  • The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
  • 2 of the 8 ancestors have a recall of any class.
  • Of its descendants, K080243 (San Cheong Co., Ltd., 2009) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K031983.

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—

What is it indicated for?

The Cyl-Fil Oxygen System is intended to provide supplemental oxygen by prescription only. Cyl-Fil is a two component system. The first component consists of a high pressure regulator that delivers USP oxygen from a supply cylinder having two pressure settings. The second component is a light-weight portable, high pressure cylinder that is refilled by use of the Cyl-Fil pressure regulator.

The intended patient population is to supply, by prescription only, supplemental oxygen to patients requiring additional oxygen.

Indications for use as stated in the FDA summary.

Also cleared against K031983

2 other devices cite the same predicate.

  • K060751Inovo, Inc. Accupulse Single Lumen Conserving RegulatorInovo, Inc. · 20061 recall
  • K051540Inovo, Inc. Independence Oxygen Conserving RegulatorInovo, Inc. · 2005

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
  • K950777Oxygen RegulatorMada Medical Products, Inc. · 1995
  • K942751Vanguard Series Gas RegulatorsBuckman Co., Inc. · 1995

https://510kreport.com/device/K061785 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061785: Cyl-Fil Oxygen System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061785

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026