510(k) · Cleared

Recalled · Class II · 2016

Devilbiss Suction Unit

K982304510(k) TraditionalCleared Sep 25, 199886-day reviewClass II21 CFR 878.4780Recalls 3

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. · JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered

Cleared on Sep 25, 1998 as substantially equivalent to K935218 (Schuco, Inc., 1994) after an 86-day review. Its family tree reaches back 1 generation to 1994. 26 later devices descend from it. It has been recalled 3 times.

Decided: Sep 25, 1998
Review: 86 days
Class: Class II
Product code: JCX
Recalls: 3
Predicates: 2

Its longest line of descent runs back 1 generation to K935218 (1994). 26 later devices descend from it, 8 citing it directly.

By dateBy generation

Root · 1 generation backK935218 Schuco-Vac Model 178Schuco, Inc. · 1994
This deviceK982304 Devilbiss Suction UnitSunrise Medical Hhg, Inc. · 1998
Descendant · cites it directly · 16 of its ownK063448 Emg AC/DC Suction UnitEmg Technology Co., Ltd. · 2006
Descendant · cites it directly · 15 of its ownK082762 Aardvark Nasal Irrigation and Aspiration DeviceAardvark Medical · 2008
Descendant · cites it directly · 13 of its ownK090379 Avita Nasal Aspirator, Model, NS1 SeriesAvita Corporation · 2010
Descendant · 2 generations on · 10 of its ownK180863 FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal AspiratorTaidoc Technology Corporation · 2018
Descendant · 2 generations on · 9 of its ownK222547 Electric nasal aspiratorShenzhen Xinlianfeng Technology Co.,Ltd · 2022

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2006high 6 (2026) · low 0 (2007)2026

Most influential descendants

Showing 5 of 26 · See all

K063448Emg AC/DC Suction UnitEmg Technology Co., Ltd. · 2006 · cites it directly16descendants
K082762Aardvark Nasal Irrigation and Aspiration DeviceAardvark Medical · 2008 · cites it directly15descendants
K090379Avita Nasal Aspirator, Model, NS1 SeriesAvita Corporation · 2010 · cites it directly13descendants
K180863FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal AspiratorTaidoc Technology Corporation · 2018 · 2 generations on10descendants
K222547Electric nasal aspiratorShenzhen Xinlianfeng Technology Co.,Ltd · 2022 · 2 generations on9descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K935218	Schuco-Vac Model 178	Schuco, Inc.	1994	—
0 (this device)	K982304	Devilbiss Suction Unit	Sunrise Medical Hhg, Inc.	1998	—
+1	K063448	Emg AC/DC Suction Unit	Emg Technology Co., Ltd.	2006	—
+1	K082762	Aardvark Nasal Irrigation and Aspiration Device	Aardvark Medical	2008	—
+1	K090379	Avita Nasal Aspirator, Model, NS1 Series	Avita Corporation	2010	—
+2	K180863	FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator	Taidoc Technology Corporation	2018	—
+2	K222547	Electric nasal aspirator	Shenzhen Xinlianfeng Technology Co.,Ltd	2022	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2008	2	0
2010	2	0
2011	1	0
2012	1	0
2013	2	0
2014	1	0
2018	1	0
2019	1	0
2022	1	0
2024	4	0
2025	3	0
2026	6	0

FIG. 1 — Lineage of K982304, 1994–2026Source: 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 JCX? 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 JCX device

#1 K250964 Protable Phlegm Suction Unit (JMA D01)score 12.2 · 4 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (2)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
Kept off the family tree	K872009	DeVilbiss 7304 Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1 …0 FDA Classification: Class I Common Name: Suction Pump/Aspirator Proprietary Model #/Name: DeVilbiss Suction Unit Equivalent to Device(s): DeVilbiss 7304 FDA 510(k)#K8720094 : - mswe Schico-Vac FDA 510(k)#K935218 . Description of Device: ' - The DeVilbiss Suction Unit is a portable AC/DC powered suc…
*	K935218	Schuco-Vac Model 178 Summary page 1 …me: Suction Pump/Aspirator Proprietary Model #/Name: DeVilbiss Suction Unit Equivalent to Device(s): DeVilbiss 7304 FDA 510(k)#K8720094 : - mswe Schico-Vac FDA 510(k)#K935218 . Description of Device: ' - The DeVilbiss Suction Unit is a portable AC/DC powered suction pump. It consists of (depending on c…	Schuco, Inc.	1994	—

Also cleared against K935218: 1 other device →

What descends from it? (26)

See all 26

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

Number	Device	Applicant	Decided	Descendants
K063448	Emg AC/DC Suction Unit	Emg Technology Co., Ltd.	2006	16
K082762	Aardvark Nasal Irrigation and Aspiration Device	Aardvark Medical	2008	15
K090379	Avita Nasal Aspirator, Model, NS1 Series	Avita Corporation	2010	13
K103535	Vacplus Suction Unit	Apex Medical Corp.	2011	2
K120065	Plaxtron Suction Unit, Model 88AA51/88AA61 Series	Plaxtron Industrial (M) Sdn. Bhd.	2012	1
K080005	Sparmax Aspirator, Models TC-2000V ND VC-701	Ding Hwa Co., Ltd.	2008	1
K133196	Impact Model 323 Aspirator	Impact Instrumentation, Inc.	2014	0
K102626	Vega Medical Suction Equipment, Model SU-01/SU-DC01	Vega Technologies, Inc.	2010	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 23, 2016	Class II	Z-2246-2016	Component design/selection	A small percentage of units of 7305 Series Vacu-Aide Suction Units are experiencing premature failure during operation.
Mar 7, 2013	Class II	Z-2319-2013	Use error	End users of the DeVilbiss Disposable Suction Container/Filter had exposed the bacterial filter cartridge to fluid, thereby occluding the filter and rendering it unusable.
Oct 27, 2008	Not classified	Z-0863-2009	Device Design	Improper suction: Regulator knob does not turn properly which can affect the suction level.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K063448 (Emg Technology Co., Ltd., 2006) has gone furthest, with 16 descendants of its own.
1 other device also cites its predicate K935218.

How does its category compare?

All JCX devices

JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JCX

2in 2025

2007high 5 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JCX

30in 2019

2007high 144 (2013) · low 30 (2019)2026

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

Recalls per year · JCX

1in 2020

2007high 3 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JCX

45in 2025

2007high 227 (2021) · low 7 (2010)2025

MAUDE reports naming product code JCX, 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	0	—	0	48
2008	4	43	3	57
2009	1	—	0	34
2010	1	—	0	7
2011	2	—	2	9
2012	2	—	0	18
2013	5	144	2	12
2014	4	106	0	68
2015	0	—	0	118
2016	2	—	0	119
2017	2	—	1	102
2018	2	—	0	170
2019	3	30	0	132
2020	0	—	1	89
2021	0	—	0	227
2022	1	—	0	215
2023	1	—	0	187
2024	1	—	0	103
2025	2	—	0	45
2026	1	—	1	—

What is it indicated for?

The DeVilbiss Suction Unit is used to remove fluids from the airway or respiratory support system and infectious materials from wounds. Configurations of the device will be intended for the home, institutional, and field/transport environments. The device is for use orly on the order of a physcian or other lincensed practitioner (e.g. EMT-field use).

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/K982304 · printed Nov 6, 2026

Cite this page

510(k) Report. “K982304: Devilbiss Suction Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982304

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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