510(k) · Cleared

Cleared

OCD2001

K992935510(k) AbbreviatedCleared Jun 20, 2000294-day reviewClass II21 CFR 868.5905

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

Contemporary Products, Inc. · NFB Conserver, Oxygen

Cleared on Jun 20, 2000 as substantially equivalent to K983601 (Medical Electronic Devices, Inc., 1998) and 2 other predicates after a 294-day review. Its family tree reaches back 2 generations to 1985. 1 later device descends from it.

Decided: Jun 20, 2000
Review: 294 days
Class: Class II
Product code: NFB
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K852650 (1985). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 2 generations backK852650 Oxymatictm Electronic Oxgyen ConserverChad Therapeutics, Inc. · 1985
1 generation backK983601 Demand Oxygen Conserving Device, Docd, the DocMedical Electronic Devices, Inc. · 1998
This deviceK992935 OCD2001Contemporary Products, Inc. · 2000
Descendant · cites it directly · 0 of its ownK022865 6203Contemporary Products, Inc. · 2003

Most influential descendants

Showing 1 of 1 · See all

K0228656203Contemporary Products, Inc. · 2003 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K852650	Oxymatictm Electronic Oxgyen Conserver	Chad Therapeutics, Inc.	1985	—
−1	K983601	Demand Oxygen Conserving Device, Docd, the Doc	Medical Electronic Devices, Inc.	1998	—
0 (this device)	K992935	OCD2001	Contemporary Products, Inc.	2000	—
+1	K022865	6203	Contemporary Products, Inc.	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0

FIG. 1 — Lineage of K992935, 1985–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 NFB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new NFB device

#1 K250322 Respond OC Conserving Regulator (130-0800)score 10.6 · 4 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (3)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K983601	Demand Oxygen Conserving Device, Docd, the Doc Summary page 1 …Common Name: Oxygen Conserver Classification Name: Ventilator, Non-Continuous (Respirator) 21CFR 868.5905 Predicate Devices 1. Medical Electronic Devices Corp. DOCD (K983601) 2. Invacare IPD Oxygen Conserving Device (K953852) 3. Chad Therapeutics, Inc. Oxymatic Electronic Oxygen Conserver (K852650) In…	Medical Electronic Devices, Inc.	1998	—
*	K953852	Model Ipd Oxygen Conserving Device Summary page 1 …Ventilator, Non-Continuous (Respirator) 21CFR 868.5905 Predicate Devices 1. Medical Electronic Devices Corp. DOCD (K983601) 2. Invacare IPD Oxygen Conserving Device (K953852) 3. Chad Therapeutics, Inc. Oxymatic Electronic Oxygen Conserver (K852650) Intended Use The OCD2001 is indicated for use to con…	Invacare Corp.	1995	—
*	K852650	Oxymatictm Electronic Oxgyen Conserver Summary page 1 …1. Medical Electronic Devices Corp. DOCD (K983601) 2. Invacare IPD Oxygen Conserving Device (K953852) 3. Chad Therapeutics, Inc. Oxymatic Electronic Oxygen Conserver (K852650) Intended Use The OCD2001 is indicated for use to conserve oxygen for patients prescribed 1/2 to 6 liters per minute of supplem…	Chad Therapeutics, Inc.	1985	—

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K022865	6203	Contemporary Products, Inc.	2003	0

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 15 years and passes through 3 companies; a new generation was cleared every 13.3 years on median.
None of the 3 ancestors has a recall.
Of its descendants, K022865 (Contemporary Products, Inc., 2003) has gone furthest, with 0 descendants of its own.

How does its category compare?

All NFB devices

NFB Conserver, Oxygen: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NFB

1in 2025

2007high 2 (2022) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NFB

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

Recalls per year · NFB

3in 2007

2007high 3 (2007) · low 0 (2008)2026

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

Adverse event reports per year · NFB

8in 2025

2007high 9 (2017) · low 0 (2008)2025

MAUDE reports naming product code NFB, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	1	—	3	3
2008	0	—	0	0
2009	1	—	0	0
2010	1	—	0	0
2011	1	—	0	1
2012	0	—	0	3
2013	1	—	0	5
2014	0	—	0	2
2015	0	—	0	4
2016	1	—	0	0
2017	0	—	0	9
2018	0	—	0	0
2019	0	—	0	0
2020	1	—	0	3
2021	0	—	0	2
2022	2	—	0	1
2023	0	—	0	4
2024	0	—	0	1
2025	1	—	0	8
2026	0	—	0	—

What is it indicated for?

The OCD2001 Demand Oxygen Conserving Device is indicated for use to conserve oxygen for patients prescribed 1/2 to 6 liters per minute of supplemental oxygen and use nasal cannulas and USP bottled oxygen.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K992935 · printed Nov 4, 2026

Cite this page

510(k) Report. “K992935: OCD2001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992935

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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