510(k) · Cleared

Cleared

Baxter Nebulizer Cap Model 2D0868

K962161510(k) TraditionalCleared Aug 15, 199672-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

Baxter Healthcare Corp · CAF Nebulizer (Direct Patient Interface)

Cleared on Aug 15, 1996 as substantially equivalent to K780406 (Travenol Laboratories, S.A., 1978) after a 72-day review. Its family tree reaches back 1 generation to 1978. 1 later device descends from it.

Decided: Aug 15, 1996
Review: 72 days
Class: Class II
Product code: CAF
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K780406 (1978). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK780406 2C7153 Nebulizer CapTravenol Laboratories, S.A. · 1978
This deviceK962161 Baxter Nebulizer Cap Model 2D0868Baxter Healthcare Corp · 1996
Descendant · cites it directly · 0 of its ownK072119 Airlife Nebulizer CapCardinalhealth · 2007

Most influential descendants

Showing 1 of 1 · See all

K072119Airlife Nebulizer CapCardinalhealth · 2007 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K780406	2C7153 Nebulizer Cap	Travenol Laboratories, S.A.	1978	—
0 (this device)	K962161	Baxter Nebulizer Cap Model 2D0868	Baxter Healthcare Corp	1996	—
+1	K072119	Airlife Nebulizer Cap	Cardinalhealth	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0

FIG. 1 — Lineage of K962161, 1978–2007Source: 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
*	K780406	2C7153 Nebulizer Cap Summary page 1 …8 Contact Person: Ed Ransom Date of Summary: 04/26/96 Trade Name: Baxter Nebulizer Cap Classification Name: Nebulizer Cap Predicate Device: Baxter Healthcare Corporation K780406 Device Description/ All blueprints dimension and specifications are exactly Comparison: the same in this device as found in the…	Travenol Laboratories, S.A.	1978	—

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
K072119	Airlife Nebulizer Cap	Cardinalhealth	2007	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?

Its one ancestor has no recall.
Of its descendants, K072119 (Cardinalhealth, 2007) 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 Baxter Healthcare Corporation’s Nebulizer Cap is for use with Sterile Water for Inhalation, USP, in 500 ml, 1000 ml, and 1500 ml plastic bottles, for inhalation therapy only.

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/K962161 · printed Nov 6, 2026

Cite this page

510(k) Report. “K962161: Baxter Nebulizer Cap Model 2D0868.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962161

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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