# K061785: Cyl-Fil Oxygen System

- Pathway: 510(k) (Traditional)
- Applicant: Responsive Respiratory, Inc.
- Decided: Sep 7, 2006 after 76 days
- Product code: CAN (Regulator, Pressure, Gas Cylinder)
- Device class: 1
- Regulation: 21 CFR 868.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K963247 (1996). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031983: Inovo, Inc, Economizer Conserving Regulator, Inovo, Inc. (2003) Summary page 1.
- K891771: Victor Medical Oxygen Therapy Regulator, Modified, Thermadyne Holings Corp. (1989) Summary page 1.
- K950777: Oxygen Regulator, Mada Medical Products, Inc. (1995) Summary page 2.
- K780359: Oxygen Regulator/Flowmeter, Erie Mfg., Co. (1978) Summary page 2.
- K901831: Precision Medical Oxygen Regulator, Precision Medical, Inc. (1990) Summary page 2.
- (no number) Sherwood Valve Co. a division of Harsco Corp.: named in the summary without a submission number
- (no number) Cavagna Group: named in the summary without a submission number

## Most influential descendants
- K080243: Portable Oxygen Unit SCA900 (2009), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K061785
Methodology: https://510kreport.com/methodology