510(k) · Cleared

Cleared

MD Turbo

K051284510(k) TraditionalCleared Jun 22, 200540-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

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

Cleared on Jun 22, 2005 as substantially equivalent to K992038 (Ferraris Medical, Inc., 1999) and 2 other predicates after a 40-day review. Its family tree reaches back 2 generations to 1987.

Decided: Jun 22, 2005
Review: 40 days
Class: Class II
Product code: CAF
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K872037 (1987). 6 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK872037 AerochamberMonaghan Medical Corp. · 1987
1 generation backK960593 Smartmist Asthma Managment System, Smartmist, Model Number…Aradigm Corp. · 1996
This deviceK051284 MD TurboRespirics, Inc. · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K872037	Aerochamber	Monaghan Medical Corp.	1987	—
−1	K960593	Smartmist Asthma Managment System, Smartmist, Model Number SM-100/Smartmist…	Aradigm Corp.	1996	—
0 (this device)	K051284	MD Turbo	Respirics, Inc.	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1994	2	0
1999	1	0

FIG. 1 — Lineage of K051284, 1987–2005Source: 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
*	K992038	Pocketspacer Summary page 1 …ification Name Accessory to a Nebulizer/Metered Dose Inhaler, Spacer, Actuator Class II- 868.5630 Predicate Devices 1. Ferraris Medical Inc. - Pocket SpacerTM (K992038) 2. Medtrack Products, LLC. - Doser TM (K935955) 3. Aradigm Corporation - SmartMist Tm (K960593) Device Descript…	Ferraris Medical, Inc.	1999	—
*	K935955	DOSER Summary page 1 …Inhaler, Spacer, Actuator Class II- 868.5630 Predicate Devices 1. Ferraris Medical Inc. - Pocket SpacerTM (K992038) 2. Medtrack Products, LLC. - Doser TM (K935955) 3. Aradigm Corporation - SmartMist Tm (K960593) Device Description The Respirics Inc. MD TurboTM is a prescription ac…	Newmed Corp.	1994	—
*	K960593	Smartmist Asthma Managment System, Smartmist, Model Number SM-100/Smartmist Spirometry… Summary page 1 …te Devices 1. Ferraris Medical Inc. - Pocket SpacerTM (K992038) 2. Medtrack Products, LLC. - Doser TM (K935955) 3. Aradigm Corporation - SmartMist Tm (K960593) Device Description The Respirics Inc. MD TurboTM is a prescription accessory device designed for use with specific pressuri…	Aradigm Corp.	1996	—

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?

The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 9.1 years on median.
None of the 6 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.

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?

MD TurboTM is intended to assist with the delivery of aerosolized medications when used in conjunction with commercialized pressurized metered dose inhalers (pMDI). MD Turbo TM is also intended for use by patients to count the number of doses remaining in their pMDI.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K051284 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051284: MD Turbo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051284

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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