510(k) · Cleared

Cleared

Devilbiss Nebulizer Model 800

K993492510(k) TraditionalCleared Apr 21, 2000189-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

Sunrise Medical Hhg, Inc. · CAF Nebulizer (Direct Patient Interface)

Cleared on Apr 21, 2000 as substantially equivalent to K952249 (Devilbiss Health Care, Inc., 1996) and 2 other predicates after a 189-day review. Its family tree reaches back 1 generation to 1990. 1 later device descends from it.

Decided: Apr 21, 2000
Review: 189 days
Class: Class II
Product code: CAF
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K894555 (1990). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK894555 Pari Inhalierboy Type 37.80 Double InsulatedDura Pharmaceuticals, Inc. · 1990
This deviceK993492 Devilbiss Nebulizer Model 800Sunrise Medical Hhg, Inc. · 2000
Descendant · cites it directly · 0 of its ownK082878 Nevoni Classic, Model 6600-PONsr Comercio E Representacoes Ltda · 2008

Most influential descendants

Showing 1 of 1 · See all

K082878Nevoni Classic, Model 6600-PONsr Comercio E Representacoes Ltda · 2008 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K894555	Pari Inhalierboy Type 37.80 Double Insulated	Dura Pharmaceuticals, Inc.	1990	—
0 (this device)	K993492	Devilbiss Nebulizer Model 800	Sunrise Medical Hhg, Inc.	2000	—
+1	K082878	Nevoni Classic, Model 6600-PO	Nsr Comercio E Representacoes Ltda	2008	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0

FIG. 1 — Lineage of K993492, 1990–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K260270 FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)score 13.2 · 7 generations · no Class I recall
#2 Held for the reportin the report
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What was it cleared against? (3)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K952249	Jet Nebulizer Summary page 1 …: 2515872 FDA Classification: Class I Equivalent Legally Marketed Predicate Devices: Legally Marketed Predicate Device 510(k) Registration # Sunrise Medical Model 700 K952249 Pari LC Plus K894555 Pari PariJet K896984 Description of Device: The Sunrise Medical Model 800 Series jet nebulizer is a reusab…	Devilbiss Health Care, Inc.	1996	—
*	K894555	Pari Inhalierboy Type 37.80 Double Insulated Summary page 1 …fication: Class I Equivalent Legally Marketed Predicate Devices: Legally Marketed Predicate Device 510(k) Registration # Sunrise Medical Model 700 K952249 Pari LC Plus K894555 Pari PariJet K896984 Description of Device: The Sunrise Medical Model 800 Series jet nebulizer is a reusable hand held, small v…	Dura Pharmaceuticals, Inc.	1990	—
*	K896984	Pari I.S.-2 Summary page 1 …uivalent Legally Marketed Predicate Devices: Legally Marketed Predicate Device 510(k) Registration # Sunrise Medical Model 700 K952249 Pari LC Plus K894555 Pari PariJet K896984 Description of Device: The Sunrise Medical Model 800 Series jet nebulizer is a reusable hand held, small volume jet nebulizer.…	Dura Pharmaceuticals, Inc.	1990	—

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K082878	Nevoni Classic, Model 6600-PO	Nsr Comercio E Representacoes Ltda	2008	0

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 3 ancestors has a recall.
Of its descendants, K082878 (Nsr Comercio E Representacoes Ltda, 2008) has gone furthest, with 0 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

2007high 18 (2007) · low 3 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CAF

211in 2025

2007high 324 (2021) · low 98 (2007)2026

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

Recalls per year · CAF

1in 2018

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	18	98	1	26
2008	12	123	0	11
2009	8	163	0	15
2010	10	114	0	37
2011	10	157	1	237
2012	9	126	0	138
2013	9	238	0	217
2014	9	151	5	123
2015	8	186	3	166
2016	5	186	1	201
2017	8	253	14 (13)	256
2018	9	161	1	162
2019	3	266	0	185
2020	6	219	0	117
2021	8	324	0	161
2022	4	176	0	55
2023	8	279	0	107
2024	4	251	0	102
2025	7	211	0	191
2026	2	—	0	—

What is it indicated for?

The system is used on the order of a physician for the treatment of asthma, bronchitis and

other respiratory diseases. The nebulizer converts the liquid medication into a fine aerosol

mist which can be inhaled for home respiratory therapy. This allows the medication to be

deposited at the affected areas of the patients airway.

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

https://510kreport.com/device/K993492 · printed Nov 4, 2026

Cite this page

510(k) Report. “K993492: Devilbiss Nebulizer Model 800.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993492

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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