510(k) · Cleared

Cleared

Aerosol System

K063716510(k) TraditionalCleared Dec 28, 2007379-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

Amici, Inc. · CAF Nebulizer (Direct Patient Interface)

Cleared on Dec 28, 2007 as substantially equivalent to K873930 (Cadema Medical Products, Inc., 1987) and 1 other predicate after a 379-day review. Its family tree reaches back 1 generation to 1987.

Decided: Dec 28, 2007
Review: 379 days
Class: Class II
Product code: CAF
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K865084 (1987). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK865084 Amici Xenon Rebreathing System*Amici, Inc. · 1987
This deviceK063716 Aerosol SystemAmici, Inc. · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K865084	Amici Xenon Rebreathing System*	Amici, Inc.	1987	—
0 (this device)	K063716	Aerosol System	Amici, Inc.	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1987	1	0

FIG. 1 — Lineage of K063716, 1987–2007Source: 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
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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K873930	Aerosol Delivery System (Aero-Tech II) Summary page 1 …er Classification Name: Nebulizer (Direct Patient Interface) [21CFR868.5630] Product Code: CAF Predicate Device: CIS-US (1219718) Aerotech Aerosol Delivery System (K873930 licensed from Cadema Medical Products) and AMICI Xenon System (K865084) Device Description: The AeroSoITM Radioaerosol System…	Cadema Medical Products, Inc.	1987	—
*	K865084	Amici Xenon Rebreathing System* Summary page 1 ….5630] Product Code: CAF Predicate Device: CIS-US (1219718) Aerotech Aerosol Delivery System (K873930 licensed from Cadema Medical Products) and AMICI Xenon System (K865084) Device Description: The AeroSoITM Radioaerosol System generates and administers a fine droplet aerosol to the breathing areas…	Amici, Inc.	1987	—

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 2 ancestors has a recall.

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. 2007, this device’s year, is highlighted.

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 AeroSol T m Radioaerosol System is intended to deliver an aerosol of diagnostic nuclear medicine to the lung for imaging. The device is intended for patients undergoing diagnostic nuclear lung ventilation imaging in a hospital or settings where nuclear medicine clinical testing is performed.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K063716 · printed Nov 4, 2026

Cite this page

510(k) Report. “K063716: Aerosol System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063716

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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