510(k) Report

510(k) · Cleared

Cleared

LC Star Reusable Nebulizer 22F50 and LC Star Disposable Nebulizer 22F70

K963924510(k) TraditionalCleared Dec 10, 199671-day reviewClass II21 CFR 868.5630

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

Pari Holding Co. · CAF Nebulizer (Direct Patient Interface)

Cleared on Dec 10, 1996 after a 71-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 26 later devices descend from it.

Decided
Dec 10, 1996
Review
71 days
Class
Class II
Product code
CAF
Recalls
None
Predicates
0

26 later devices descend from it, 11 citing it directly.

Descendants, by year cleared 2008: 2 descendants cleared2006: 3 descendants cleared2004: 2 descendants cleared2012: 1 descendant cleared2003: 1 descendant cleared2007: 4 descendants cleared2010: 3 descendants cleared2005: 1 descendant cleared2017: 2 descendants cleared2009: 1 descendant cleared2023: 1 descendant cleared2011: 1 descendant cleared2015: 1 descendant cleared2020: 1 descendant cleared2013: 1 descendant cleared2025: 1 descendant cleared1995200020052010201520202025
  1. This deviceK963924 LC Star Reusable Nebulizer 22F50 and LC Star Disposable Nebulizer…Pari Holding Co. · 1996
  2. Descendant · cites it directly · 10 of its ownK033833 Eflow Electronic Inhaler/NebulizerPari Innovative Manufacturers, Inc. · 2004
  3. Descendant · 2 generations on · 5 of its ownK072670 Modification to: Eflow Electronic Inhaler/NebulizerPari Innovative Manufacturers, Inc. · 2007
  4. Descendant · cites it directly · 5 of its ownK061381 LC Star with Nasal AdapterPari Innovative Manufacturers, Inc. · 2006
  5. Descendant · cites it directly · 4 of its ownK100380 Altera Nebulizer System, Model 678G1002Pari Respiratory Equipment, Inc. · 2010
  6. Descendant · cites it directly · 3 of its ownK112859 Erapid Nebulizer SystemPari Respiratory Equipment, Inc. · 2012

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2003: 12004: 22005: 12006: 32007: 42008: 22009: 12010: 32011: 12012: 12013: 12015: 12017: 22020: 12023: 12025: 1
2003high 4 (2007) · low 0 (2014)2026

Most influential descendants

Showing 5 of 26 · See all
  • K033833Eflow Electronic Inhaler/NebulizerPari Innovative Manufacturers, Inc. · 2004 · cites it directly10descendants
  • K072670Modification to: Eflow Electronic Inhaler/NebulizerPari Innovative Manufacturers, Inc. · 2007 · 2 generations on5descendants
  • K061381LC Star with Nasal AdapterPari Innovative Manufacturers, Inc. · 2006 · cites it directly5descendants
  • K100380Altera Nebulizer System, Model 678G1002Pari Respiratory Equipment, Inc. · 2010 · cites it directly4descendants
  • K112859Erapid Nebulizer SystemPari Respiratory Equipment, Inc. · 2012 · cites it directly3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K963924LC Star Reusable Nebulizer 22F50 and LC Star Disposable Nebulizer 22F70Pari Holding Co.1996—
+1K033833Eflow Electronic Inhaler/NebulizerPari Innovative Manufacturers, Inc.2004—
+2K072670Modification to: Eflow Electronic Inhaler/NebulizerPari Innovative Manufacturers, Inc.2007—
+1K061381LC Star with Nasal AdapterPari Innovative Manufacturers, Inc.2006—
+1K100380Altera Nebulizer System, Model 678G1002Pari Respiratory Equipment, Inc.2010—
+1K112859Erapid Nebulizer SystemPari Respiratory Equipment, Inc.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200420
200510
200630
200740
200820
200910
201030
201110
201210
201310
201510
201720
202010
202310
202510
FIG. 1 — Lineage of K963924, 1996–2025Source: 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 CAF? 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 CAF device

  1. #1 K260270 FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)score 13.2 · 7 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? (26)

See all 26

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

NumberDeviceApplicantDecidedDescendants
K033833Eflow Electronic Inhaler/NebulizerPari Innovative Manufacturers, Inc.200410
K061381LC Star with Nasal AdapterPari Innovative Manufacturers, Inc.20065
K100380Altera Nebulizer System, Model 678G1002Pari Respiratory Equipment, Inc.20104
K112859Erapid Nebulizer SystemPari Respiratory Equipment, Inc.20123
K060399LC Sprint NebulizerPari Innovative Manufacturers, Inc.20063
K032170Transneb Compressor W/Nebulizer, Model 5000Medical Industries America, Inc.20043
K032849Aeroneb GO Nebulizer, Model AG-AG2000Aerogen, Inc.20031
K082541Healthline Medicator / Redineb Aerosol Drug Delivery SystemMedi Nuclear Corp., Inc.20080
K072163Happyneb II, Happyneb Iii, Speedy, Nebby Plus and Myneb, Model 53A Health Care S.R.L.20080
K062484Flaem Nuova RF6 Basic and RF6 Plus NebulizersFlaem 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?

  • Of its descendants, K033833 (Pari Innovative Manufacturers, Inc., 2004) has gone furthest, with 10 descendants of its own.

How does its category compare?

All CAF devices

CAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CAF

7in 2025

2007: 182008: 122009: 82010: 102011: 102012: 92013: 92014: 92015: 82016: 52017: 82018: 92019: 32020: 62021: 82022: 42023: 82024: 42025: 72026 (partial year): 2
2007high 18 (2007) · low 3 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CAF

211in 2025

2007: 98 days median2008: 123 days median2009: 163 days median2010: 114 days median2011: 157 days median2012: 126 days median2013: 238 days median2014: 151 days median2015: 186 days median2016: 186 days median2017: 253 days median2018: 161 days median2019: 266 days median2020: 219 days median2021: 324 days median2022: 176 days median2023: 279 days median2024: 251 days median2025: 211 days median
2007high 324 (2021) · low 98 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · CAF

1in 2018

2007: 12011: 12014: 52015: 32016: 12017: 14, 13 Class I2018: 1
2007high 14 (2017) · low 0 (2008)2026

Class I (13 since 2007) Class II/III not classified

Adverse event reports per year · CAF

191in 2025

2007: 262008: 112009: 152010: 372011: 2372012: 1382013: 2172014: 1232015: 1662016: 2012017: 2562018: 1622019: 1852020: 1172021: 1612022: 552023: 1072024: 1022025: 191
2007high 256 (2017) · low 11 (2008)2025

MAUDE reports naming product code CAF, 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
20071898126
200812123011
20098163015
201010114037
2011101571237
201291260138
201392380217
201491515123
201581863166
201651861201
2017825314 (13)256
201891611162
201932660185
202062190117
202183240161
20224176055
202382790107
202442510102
202572110191
20262—0—

More from Pari Holding Co.

8 FDA decisions under this applicant name. See the company

  • K002862Proneb Ultra Model Number 85B0100Pari Holding Co. · 2001
  • K983308RC Cornet, Model #44F50Pari Holding Co. · 1999
  • K972042Pari Pep Therapy SystemPari Holding Co. · 1997
  • K962072Proneb Turbo Compressor Model 38V0200Pari Holding Co. · 1996
  • K960675Walkhaler Portable Compressor Model 45F70Pari Holding Co. · 1996

Recent decisions in CAF

The CAF category page

  • K254171Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210)Shenzhen Mericonn Technology Co., Ltd. · 2026
  • K260270FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)FindAir Sp. z o.o. · 2026
  • K251572eRapid with eTrack SystemPari Respiratory Equipment, Inc. · 2025
  • K251659Mesh Nebulizer (H6)Qingdao Future Medical Technology Co., Ltd. · 2025
  • K244035Portable mesh nebulizer (JM821)Shenzhen Jermei Medical Device Technology Co., Ltd. · 2025

https://510kreport.com/device/K963924 · printed Nov 4, 2026

Cite this page

510(k) Report. “K963924: LC Star Reusable Nebulizer 22F50 and LC Star Disposable Nebulizer 22F70.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963924

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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