510(k) Report

510(k) · Cleared

Cleared

Mister Neb Nebulizer Compressor, with Nebulizer, Model HS123

K013027510(k) TraditionalCleared Dec 6, 200187-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

Respironics Healthscan, Inc. · BTI Compressor, Air, Portable

Cleared on Dec 6, 2001 as substantially equivalent to K914251 (Invacare Corp., 1992) after an 87-day review. Its family tree reaches back 1 generation to 1992. 6 later devices descend from it.

Decided
Dec 6, 2001
Review
87 days
Class
Class II
Product code
BTI
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K914251 (1992). 6 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2004: 3 descendants cleared2007: 1 descendant cleared2005: 1 descendant cleared2009: 1 descendant clearedK914251 · Model Irc Passport Nebulizer · Invacare Corp. · 19921990200020102020
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 1 descendant K914251 · Model Irc Passport Nebulizer · Invacare Corp. · 19920
  1. Root · 1 generation backK914251 Model Irc Passport NebulizerInvacare Corp. · 1992
  2. This deviceK013027 Mister Neb Nebulizer Compressor, with Nebulizer, Model HS123Respironics Healthscan, Inc. · 2001
  3. Descendant · cites it directly · 4 of its ownK031908 MED2000 Spa Nebulizer Compressors, Models P1 and P2, with Nebulizer…Med2000 S.R.L. · 2004
  4. Descendant · 2 generations on · 1 of its ownK051365 Compressor Nebulizer System, Model KN-9321K-Jump Health Co., Ltd. · 2005
  5. Descendant · 3 generations on · 0 of its ownK083256 Ultrasonic Nebulizer System, Model KN-9210K-Jump Health Co., Ltd. · 2009
  6. Descendant · cites it directly · 0 of its ownK062014 Families of Master Neb, Primo Neb, SC03, Neb Aid, 4.2.Neb, Q03…Flaem Nuova S.P.A. · 2007
  7. Descendant · 2 generations on · 0 of its ownK041974 MED2000 Nebulizer Compressor, Models P3, P4, P5 with NebulizerMed2000 S.R.L. · 2004

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2004: 32005: 12007: 12009: 1
2004high 3 (2004) · low 0 (2006)2026

Most influential descendants

Showing 5 of 6 · See all
  • K031908MED2000 Spa Nebulizer Compressors, Models P1 and P2, with Nebulizer, and MED2000 Spa…Med2000 S.R.L. · 2004 · cites it directly4descendants
  • K051365Compressor Nebulizer System, Model KN-9321K-Jump Health Co., Ltd. · 2005 · 2 generations on1descendant
  • K083256Ultrasonic Nebulizer System, Model KN-9210K-Jump Health Co., Ltd. · 2009 · 3 generations on0descendants
  • K062014Families of Master Neb, Primo Neb, SC03, Neb Aid, 4.2.Neb, Q03, FJ03, and Walkie-NebFlaem Nuova S.P.A. · 2007 · cites it directly0descendants
  • K041974MED2000 Nebulizer Compressor, Models P3, P4, P5 with NebulizerMed2000 S.R.L. · 2004 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K914251Model Irc Passport NebulizerInvacare Corp.1992—
0 (this device)K013027Mister Neb Nebulizer Compressor, with Nebulizer, Model HS123Respironics Healthscan, Inc.2001—
+1K031908MED2000 Spa Nebulizer Compressors, Models P1 and P2, with Nebulizer, and…Med2000 S.R.L.2004—
+2K051365Compressor Nebulizer System, Model KN-9321K-Jump Health Co., Ltd.2005—
+3K083256Ultrasonic Nebulizer System, Model KN-9210K-Jump Health Co., Ltd.2009—
+1K062014Families of Master Neb, Primo Neb, SC03, Neb Aid, 4.2.Neb, Q03, FJ03, and…Flaem Nuova S.P.A.2007—
+2K041974MED2000 Nebulizer Compressor, Models P3, P4, P5 with NebulizerMed2000 S.R.L.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200430
200510
200710
200910
FIG. 1 — Lineage of K013027, 1992–2009Source: 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), 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 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? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K914251Model Irc Passport Nebulizer
Summary page 1
…Prepared: August 8, 2001 2. Name of the Device: Mister Neb™ Nebulizer Compressor, with Nebulizer, Model HS123 3. Predicate Device Information: InvaCare Envoy Jr., K#t 914251 4. Device Description: This line-powered piston compressor is housed in a plastic cabinet (case). Dimensions are 7.3 in. x 6.9…
Invacare Corp.1992—

Also cleared against K914251: 1 other device →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K031908MED2000 Spa Nebulizer Compressors, Models P1 and P2, with Nebulizer, and MED2000 Spa…Med2000 S.R.L.20044
K062014Families of Master Neb, Primo Neb, SC03, Neb Aid, 4.2.Neb, Q03, FJ03, and Walkie-NebFlaem Nuova S.P.A.20070

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?

  • Its one ancestor has no recall.
  • Of its descendants, K031908 (Med2000 S.R.L., 2004) has gone furthest, with 4 descendants of its own.
  • 1 other device also cites its predicate K914251.

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—

What is it indicated for?

This nebulizer compressor is an AC-powered air compressor intended to provide a source of compressed air for medical purposes for use in home health care.

This device is used in conjunction with a pneumatic nebulizer to produce a fine aerosol mist of medication for respiratory therapy, for both children and adults suffering from respiratory disorders such as asthma, allergies, COPD, etc.

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

Also cleared against K914251

1 other device cites the same predicate.

  • K992643Model Irc 1001 Aerosol CompressorInvacare Corp. · 1999

More from Respironics Healthscan, Inc.

2 FDA decisions under this applicant name. See the company

  • K032809Hospital SpacerRespironics Healthscan, Inc. · 2003

Recent decisions in BTI

The BTI category page

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  • K060781Medical Compressor, Models DK50 D and DMEkom S.R.O. · 2006

https://510kreport.com/device/K013027 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013027: Mister Neb Nebulizer Compressor, with Nebulizer, Model HS123.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013027

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026