510(k) Report

510(k) · Cleared

Cleared

PM 1800 Conserving Device

K001412510(k) AbbreviatedCleared Mar 20, 2001320-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

Precision Medical, Inc. · NFB Conserver, Oxygen

Cleared on Mar 20, 2001 after a 320-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.

Decided
Mar 20, 2001
Review
320 days
Class
Class II
Product code
NFB
Recalls
None
Predicates
0

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

Descendants, by year cleared 2002: 1 descendant cleared2006: 1 descendant cleared2007: 1 descendant cleared2025: 1 descendant cleared200020052010201520202025
  1. This deviceK001412 PM 1800 Conserving DevicePrecision Medical, Inc. · 2001
  2. Descendant · cites it directly · 3 of its ownK020475 Chad Therapeutics Oxypenumatic Cypress Model 511Chad Therapeutics, Inc. · 2002
  3. Descendant · 2 generations on · 1 of its ownK070740 Chad Therapeutics Bonsai Model 800Chad Therapeutics, Inc. · 2007
  4. Descendant · 3 generations on · 0 of its ownK250322 Respond OC Conserving Regulator (130-0800)Responsive Respiratory · 2025
  5. Descendant · 2 generations on · 0 of its ownK060751 Inovo, Inc. Accupulse Single Lumen Conserving RegulatorInovo, Inc. · 2006 · Recalled

Most influential descendants

Showing 4 of 4 · See all
  • K020475Chad Therapeutics Oxypenumatic Cypress Model 511Chad Therapeutics, Inc. · 2002 · cites it directly3descendants
  • K070740Chad Therapeutics Bonsai Model 800Chad Therapeutics, Inc. · 2007 · 2 generations on1descendant
  • K250322Respond OC Conserving Regulator (130-0800)Responsive Respiratory · 2025 · 3 generations on0descendants
  • K060751Inovo, Inc. Accupulse Single Lumen Conserving RegulatorInovo, Inc. · 2006 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001412PM 1800 Conserving DevicePrecision Medical, Inc.2001—
+1K020475Chad Therapeutics Oxypenumatic Cypress Model 511Chad Therapeutics, Inc.2002—
+2K070740Chad Therapeutics Bonsai Model 800Chad Therapeutics, Inc.2007—
+3K250322Respond OC Conserving Regulator (130-0800)Responsive Respiratory2025—
+2K060751Inovo, Inc. Accupulse Single Lumen Conserving RegulatorInovo, Inc.20061

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200610
200710
202510
FIG. 1 — Lineage of K001412, 2001–2025Source: 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 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. #1 K250322 Respond OC Conserving Regulator (130-0800)score 10.6 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K020475Chad Therapeutics Oxypenumatic Cypress Model 511Chad Therapeutics, Inc.20023

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?

  • Of its descendants, K020475 (Chad Therapeutics, Inc., 2002) has gone furthest, with 3 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

2007: 12009: 12010: 12011: 12013: 12016: 12020: 12022: 22025: 1
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

2007: 3
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

2007: 32011: 12012: 32013: 52014: 22015: 42017: 92020: 32021: 22022: 12023: 42024: 12025: 8
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—33
20080—00
20091—00
20101—00
20111—01
20120—03
20131—05
20140—02
20150—04
20161—00
20170—09
20180—00
20190—00
20201—03
20210—02
20222—01
20230—04
20240—01
20251—08
20260—0—
Cite this page

510(k) Report. “K001412: PM 1800 Conserving Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001412

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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