510(k) Report

510(k) · Cleared

Cleared

Devilbiss Model 4650 Compressor Neubulizer

K931015510(k) TraditionalCleared Sep 30, 1993216-day reviewClass II21 CFR 868.6250

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

Devilbiss Health Care, Inc. · BTI Compressor, Air, Portable

Cleared on Sep 30, 1993 after a 216-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Sep 30, 1993
Review
216 days
Class
Class II
Product code
BTI
Recalls
None
Predicates
0

2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared1997: 1 descendant cleared1990200020102020
  1. This deviceK931015 Devilbiss Model 4650 Compressor NeubulizerDevilbiss Health Care, Inc. · 1993
  2. Descendant · cites it directly · 0 of its ownK112824 Quality Life Technologies Compressor NebulizerQuality Life Technologies Co;Ltd · 2012
  3. Descendant · cites it directly · 0 of its ownK970035 John Bunn Neb-U-Lite II Medication Compressor with Disposable…Graham-Field, Inc. · 1997

Most influential descendants

Showing 2 of 2 · See all
  • K112824Quality Life Technologies Compressor NebulizerQuality Life Technologies Co;Ltd · 2012 · cites it directly0descendants
  • K970035John Bunn Neb-U-Lite II Medication Compressor with Disposable Nebulizer, Model…Graham-Field, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K931015Devilbiss Model 4650 Compressor NeubulizerDevilbiss Health Care, Inc.1993—
+1K112824Quality Life Technologies Compressor NebulizerQuality Life Technologies Co;Ltd2012—
+1K970035John Bunn Neb-U-Lite II Medication Compressor with Disposable Nebulizer, Model…Graham-Field, Inc.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
201210
FIG. 1 — Lineage of K931015, 1993–2012Source: 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 BTI? 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? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K112824Quality Life Technologies Compressor NebulizerQuality Life Technologies Co;Ltd20120
K970035John Bunn Neb-U-Lite II Medication Compressor with Disposable Nebulizer, Model…Graham-Field, Inc.19970

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, K112824 (Quality Life Technologies Co;Ltd, 2012) has gone furthest, with 0 descendants of its own.

How does its category compare?

All BTI devices

BTI Compressor, Air, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BTI

1in 2013

2008: 12009: 12012: 12013: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BTI

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

Recalls per year · BTI

3in 2023

2007: 12013: 12023: 3, 3 Class I
2007high 3 (2023) · low 0 (2008)2026

Class I (3 since 2007) Class II/III not classified

Adverse event reports per year · BTI

120in 2025

2007: 182008: 92009: 72010: 112011: 132012: 2172013: 1,7102014: 9822015: 2942016: 1392017: 1032018: 712019: 1142020: 1112021: 2782022: 2482023: 3252024: 1662025: 120
2007high 1,710 (2013) · low 7 (2009)2025

MAUDE reports naming product code BTI, 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—118
20081—09
20091—07
20100—011
20110—013
20121—0217
20131—11,710
20140—0982
20150—0294
20160—0139
20170—0103
20180—071
20190—0114
20200—0111
20210—0278
20220—0248
20230—3 (3)325
20240—0166
20250—0120
20260—0—

More from Devilbiss Health Care, Inc.

29 FDA decisions under this applicant name. See the company

  • K963349Devilbiss 8650DDevilbiss Health Care, Inc. · 1997
  • K970289Compressor/Nebulizer #3650Devilbiss Health Care, Inc. · 1997
  • K961126Pulse Dose SeriesDevilbiss Health Care, Inc. · 1996
  • K950849MODEL #7354Devilbiss Health Care, Inc. · 1996
  • K952491MODEL 7355Devilbiss Health Care, Inc. · 1996

Recent decisions in BTI

The BTI category page

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https://510kreport.com/device/K931015 · printed Nov 6, 2026

Cite this page

510(k) Report. “K931015: Devilbiss Model 4650 Compressor Neubulizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K931015

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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