510(k) · Cleared

Recalled · Class II · 2015

Salterlabs 8960 Series Nebulizer (8960/8961/8966/8984)

K961476510(k) TraditionalCleared Jul 16, 199689-day reviewClass II21 CFR 868.5630Recalls 1

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

Salter Labs · CAF Nebulizer (Direct Patient Interface)

Cleared on Jul 16, 1996 as substantially equivalent to K870027 (Salter Labs, 1987) after an 89-day review. Its family tree reaches back 1 generation to 1987. 6 later devices descend from it. It has been recalled once.

Decided: Jul 16, 1996
Review: 89 days
Class: Class II
Product code: CAF
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K870027 (1987). 6 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK870027 Hand Held Pheumatic Powered (Disposable) NebulizerSalter Labs · 1987 · Recalled
This deviceK961476 Salterlabs 8960 Series Nebulizer (8960/8961/8966/8984)Salter Labs · 1996
Descendant · cites it directly · 5 of its ownK014056 Salter Labs Modified Nebutech NebulizerSalter Labs · 2002
Descendant · cites it directly · 4 of its ownK031908 MED2000 Spa Nebulizer Compressors, Models P1 and P2, with Nebulizer…Med2000 S.R.L. · 2004
Descendant · 2 generations on · 1 of its ownK051365 Compressor Nebulizer System, Model KN-9321K-Jump Health Co., Ltd. · 2005
Descendant · 3 generations on · 0 of its ownK083256 Ultrasonic Nebulizer System, Model KN-9210K-Jump Health Co., Ltd. · 2009
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

2002high 3 (2004) · low 0 (2003)2026

Most influential descendants

Showing 5 of 6 · See all

K014056Salter Labs Modified Nebutech NebulizerSalter Labs · 2002 · cites it directly5descendants
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
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

Generation	Number	Device	Applicant	Decided	Recalls
−1	K870027	Hand Held Pheumatic Powered (Disposable) Nebulizer	Salter Labs	1987	1
0 (this device)	K961476	Salterlabs 8960 Series Nebulizer (8960/8961/8966/8984)	Salter Labs	1996	—
+1	K014056	Salter Labs Modified Nebutech Nebulizer	Salter Labs	2002	—
+1	K031908	MED2000 Spa Nebulizer Compressors, Models P1 and P2, with Nebulizer, and…	Med2000 S.R.L.	2004	—
+2	K051365	Compressor Nebulizer System, Model KN-9321	K-Jump Health Co., Ltd.	2005	—
+3	K083256	Ultrasonic Nebulizer System, Model KN-9210	K-Jump Health Co., Ltd.	2009	—
+2	K041974	MED2000 Nebulizer Compressor, Models P3, P4, P5 with Nebulizer	Med2000 S.R.L.	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2004	3	0
2005	1	0
2009	1	0

FIG. 1 — Lineage of K961476, 1987–2009Source: 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
#3 Held for the reportin 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.

Type	Number	Device	Applicant	Decided	Recalls
*	K870027	Hand Held Pheumatic Powered (Disposable) Nebulizer Summary page 1 …eries 15.5 Identification of Predicate Device: Salter Labs Hand Held Pneumatic Powered (disposable) Nebulizer Model 8900, which was cleared for marketing by 510(k) No, K870027 15.6 Description of the Device: Each of the Salter Labs 8960 Series Nebulizers consists of a Nebulizer Top which is screwed ont…	Salter Labs	1987	1

Also cleared against K870027: 5 other devices →

What descends from it? (6)

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

Number	Device	Applicant	Decided	Descendants
K014056	Salter Labs Modified Nebutech Nebulizer	Salter Labs	2002	5
K031908	MED2000 Spa Nebulizer Compressors, Models P1 and P2, with Nebulizer, and MED2000 Spa…	Med2000 S.R.L.	2004	4

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 4, 2015	Class II	Z-2781-2015	Component change control	The Inspiratory valve cap on the nebulizer reservoir tower may be loose and may detach before or during treatment.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K014056 (Salter Labs, 2002) has gone furthest, with 5 descendants of its own.
5 other devices also cite its predicate K870027.

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 Model 8960 Series Nebulizers have the same intended use as their predicate device, The Salter Model 8900 Nebulizer, which was cleared for marketing by 510(k) No. K870027. The nebulizer is a disposable device which is used where liquids are to be delivered to a patient in an aerosol form. The device is not life-supporting or life-sustaining, nor is it implanted. It does not use software, nor is it sterile. The device is for single patient use. It is intended to be used with accessories, such as masks and tubing which are industry standard devices used with nebulizers.

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/K961476 · printed Nov 4, 2026

Cite this page

510(k) Report. “K961476: Salterlabs 8960 Series Nebulizer (8960/8961/8966/8984).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961476

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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