510(k) Report

510(k) · Cleared

Cleared

Emerson 3MV Volume Ventilator

K864394510(k) TraditionalCleared Dec 5, 198629-day review

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

J. H. Emerson Co.

Cleared on Dec 5, 1986 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 11 devices in its family, counting itself, has a Class I recall. 10 later devices descend from it.

Decided
Dec 5, 1986
Review
29 days
Recalls
None
Predicates
0

10 later devices descend from it, 1 citing it directly. 1 of the 11 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 1997: 1 descendant cleared1998: 1 descendant cleared2002: 1 descendant cleared2007: 1 descendant cleared2004: 1 descendant cleared2005: 2 descendants cleared2008: 1 descendant cleared2012: 1 descendant cleared2013: 1 descendant cleared, 1 with a Class I recall11990200020102020
  1. This deviceK864394 Emerson 3MV Volume VentilatorJ. H. Emerson Co. · 1986
  2. Descendant · cites it directly · 9 of its ownK964540 Nellcor Puritan Bennett, 740 Ventilator SystemPuritan Bennett Corp. · 1997 · Recalled
  3. Descendant · 2 generations on · 8 of its ownK984379 Nellcor Puritan Bennett, 760 Ventilator SystemPuritan Bennett Corp. · 1998 · Recalled
  4. Descendant · 3 generations on · 6 of its ownK021112 Inspiration Ventilator SystemeVent Medical, Ltd. · 2002
  5. Descendant · 4 generations on · 4 of its ownK030341 Modification to Inspiration Ventilator SystemeVent Medical, Ltd. · 2004
  6. Descendant · 5 generations on · 3 of its ownK051550 Inspiration Ventilator SystemeVent Medical, Ltd. · 2005 · Recalled

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

1997: 11998: 12002: 12004: 12005: 22007: 12008: 12012: 12013: 1
1997high 2 (2005) · low 0 (1999)2026

Class I recalls in this family

  • K130178 Inspiration Ventilator System 5I/7I7 generations on · 2013

Most influential descendants

Showing 5 of 10 · See all
  • K964540Nellcor Puritan Bennett, 740 Ventilator SystemPuritan Bennett Corp. · 1997 · cites it directly9descendants
  • K984379Nellcor Puritan Bennett, 760 Ventilator SystemPuritan Bennett Corp. · 1998 · 2 generations on8descendants
  • K021112Inspiration Ventilator SystemeVent Medical, Ltd. · 2002 · 3 generations on6descendants
  • K030341Modification to Inspiration Ventilator SystemeVent Medical, Ltd. · 2004 · 4 generations on4descendants
  • K051550Inspiration Ventilator SystemeVent Medical, Ltd. · 2005 · 5 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K864394Emerson 3MV Volume VentilatorJ. H. Emerson Co.1986—
+1K964540Nellcor Puritan Bennett, 740 Ventilator SystemPuritan Bennett Corp.19974
+2K984379Nellcor Puritan Bennett, 760 Ventilator SystemPuritan Bennett Corp.19984
+3K021112Inspiration Ventilator SystemeVent Medical, Ltd.2002—
+4K030341Modification to Inspiration Ventilator SystemeVent Medical, Ltd.2004—
+5K051550Inspiration Ventilator SystemeVent Medical, Ltd.20051

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199810
200210
200410
200520
200710
200810
201210
201311
FIG. 1 — Lineage of K864394, 1986–2013Source: 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.

1 device in this family has a Class I recall. 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? (10)

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

NumberDeviceApplicantDecidedDescendants
K964540Nellcor Puritan Bennett, 740 Ventilator SystemPuritan Bennett Corp.19979

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd. · 2013 · 7 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K964540 (Puritan Bennett Corp., 1997) has gone furthest, with 9 descendants of its own.

More from J. H. Emerson Co.

25 FDA decisions under this applicant name. See the company

  • K002598Emerson Cough Assist Model CA-3000 W/Automatic Timing and Model CM-3000 W/Manual TimingJ. H. Emerson Co. · 2000
  • K920910Oxygen Powered Resuscitator for CPRJ. H. Emerson Co. · 1993
  • K924174Emerson in-Exsufflator, Models 2-CM & 2-CAJ. H. Emerson Co. · 1992
  • K902764Emerson 33-an Negative Pressure Respirator AlarmJ. H. Emerson Co. · 1990
  • K896721Model 7-at Treatment ChamberJ. H. Emerson Co. · 1990

https://510kreport.com/device/K864394 · printed Nov 4, 2026

Cite this page

510(k) Report. “K864394: Emerson 3MV Volume Ventilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K864394

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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