510(k) Report

510(k) · Cleared

Cleared

Vortex Valved Holding Chamber

K020944510(k) TraditionalCleared May 9, 200245-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 Innovative Manufacturers, Inc. · CAF Nebulizer (Direct Patient Interface)

Cleared on May 9, 2002 as substantially equivalent to K992917 (Trudell Medical Int'L, 1999) and 6 other predicates after a 45-day review. Its family tree reaches back 1 generation to 1982.

Decided
May 9, 2002
Review
45 days
Class
Class II
Product code
CAF
Recalls
None
Predicates
7

Its longest line of descent runs back 1 generation to K822437 (1982). 7 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1999: 1 other ancestor1994: 1 other ancestor1991: 2 other ancestors1989: 1 other ancestor1987: 1 other ancestorK822437 · Monaghan Aerochamber · Monaghan Medical Corp. · 198219801985199019952000
Other ancestors, by generation 1 generation back: 6 other ancestors K822437 · Monaghan Aerochamber · Monaghan Medical Corp. · 19820
  1. Root · 1 generation backK822437 Monaghan AerochamberMonaghan Medical Corp. · 1982
  2. This deviceK020944 Vortex Valved Holding ChamberPari Innovative Manufacturers, Inc. · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K822437Monaghan AerochamberMonaghan Medical Corp.1982—
0 (this device)K020944Vortex Valved Holding ChamberPari Innovative Manufacturers, Inc.2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
198910
199120
199410
199910
FIG. 1 — Lineage of K020944, 1982–2002Source: 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 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
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What was it cleared against? (7)

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
*K992917Aerochamber Plus Valved Holding Chamber
Summary page 1
…ex® Classification Name: Nebulizer (Direct Patient Interface) Legally Marketed Predicate Device Aerochamber Monaghan Medical (and/or Trudell Medical) Plattsburgh, NY K992917; K930574; K900576; K900557; K884803; K872037; K822437 Device Description Vortex is a new spacer/holding chamber designed to assi…
Trudell Medical Int'L1999—
*K930574Aerochamber W/Mask, Modified
Summary page 1
…sification Name: Nebulizer (Direct Patient Interface) Legally Marketed Predicate Device Aerochamber Monaghan Medical (and/or Trudell Medical) Plattsburgh, NY K992917; K930574; K900576; K900557; K884803; K872037; K822437 Device Description Vortex is a new spacer/holding chamber designed to assist patien…
Monaghan Medical Corp.1994—
*K900576Modified Aerochamber with Mask
Summary page 1
…n Name: Nebulizer (Direct Patient Interface) Legally Marketed Predicate Device Aerochamber Monaghan Medical (and/or Trudell Medical) Plattsburgh, NY K992917; K930574; K900576; K900557; K884803; K872037; K822437 Device Description Vortex is a new spacer/holding chamber designed to assist patients using…
Monaghan Medical Corp.1991—
*K900557Modified Aerochamber M.V. Aerosol Holding Chamber
Summary page 1
…Nebulizer (Direct Patient Interface) Legally Marketed Predicate Device Aerochamber Monaghan Medical (and/or Trudell Medical) Plattsburgh, NY K992917; K930574; K900576; K900557; K884803; K872037; K822437 Device Description Vortex is a new spacer/holding chamber designed to assist patients using metered d…
Monaghan Medical Corp.1991—
*K884803Aerochamber M.V.
Summary page 1
…(Direct Patient Interface) Legally Marketed Predicate Device Aerochamber Monaghan Medical (and/or Trudell Medical) Plattsburgh, NY K992917; K930574; K900576; K900557; K884803; K872037; K822437 Device Description Vortex is a new spacer/holding chamber designed to assist patients using metered dose inhal…
Monaghan Medical Corp.1989—
*K872037Aerochamber
Summary page 1
…Patient Interface) Legally Marketed Predicate Device Aerochamber Monaghan Medical (and/or Trudell Medical) Plattsburgh, NY K992917; K930574; K900576; K900557; K884803; K872037; K822437 Device Description Vortex is a new spacer/holding chamber designed to assist patients using metered dose inhalers (MDI)…
Monaghan Medical Corp.1987—
*K822437Monaghan Aerochamber
Summary page 1
…nterface) Legally Marketed Predicate Device Aerochamber Monaghan Medical (and/or Trudell Medical) Plattsburgh, NY K992917; K930574; K900576; K900557; K884803; K872037; K822437 Device Description Vortex is a new spacer/holding chamber designed to assist patients using metered dose inhalers (MDI) for aer…
Monaghan Medical Corp.1982—

Also cleared against K992917: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • None of the 7 ancestors has a recall.
  • 3 other devices also cite its predicate K992917.

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—

What is it indicated for?

Vortex is indicated for use as a spacer/valved holding chamber for use in delivery of aerosol medication with metered dose inhalers.

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 K992917

3 other devices cite the same predicate.

  • K100285Litetouch MaskRespironics New Jersey, Inc. · 2010
  • K080100WatchhalerActivaero America, Inc. · 2008
  • K032809Hospital SpacerRespironics Healthscan, Inc. · 2003

More from Pari Innovative Manufacturers, Inc.

10 FDA decisions under this applicant name. See the company

  • K072670Modification to: Eflow Electronic Inhaler/NebulizerPari Innovative Manufacturers, Inc. · 2007
  • K072982Pari Hydrate VPari Innovative Manufacturers, Inc. · 2007
  • K070498Hyper SalPari Innovative Manufacturers, Inc. · 2007
  • K070107Pari Hydrate GPari Innovative Manufacturers, Inc. · 2007
  • K062158LC Sprint StarPari Innovative Manufacturers, Inc. · 2006

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/K020944 · printed Nov 4, 2026

Cite this page

510(k) Report. “K020944: Vortex Valved Holding Chamber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K020944

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026