510(k) · Cleared

Cleared

Smartrecorder, Model 2500

K990199510(k) TraditionalCleared Apr 19, 199988-day reviewClass II21 CFR 868.2375

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

Respironics, Inc. · MNR Ventilatory Effort Recorder

Cleared on Apr 19, 1999 as substantially equivalent to K971867 (Healthdyne Technologies, Inc., 1997) and 2 other predicates after an 88-day review. Its family tree reaches back 2 generations to 1997.

Decided: Apr 19, 1999
Review: 88 days
Class: Class II
Product code: MNR
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K971867 (1997). 3 ancestors in all, the oldest K962603 (1997). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK971867 Alice 4R SystemHealthdyne Technologies, Inc. · 1997
1 generation backK983572 Simon Multichannel Recording System, Model 5500Healthdyne Technologies, Inc. · 1999
This deviceK990199 Smartrecorder, Model 2500Respironics, Inc. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K971867	Alice 4R System	Healthdyne Technologies, Inc.	1997	—
−1	K983572	Simon Multichannel Recording System, Model 5500	Healthdyne Technologies, Inc.	1999	—
0 (this device)	K990199	Smartrecorder, Model 2500	Respironics, Inc.	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0

FIG. 1 — Lineage of K990199, 1997–1999Source: 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 MNR? 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 MNR device

#1 K244027 Sansa Hsatscore 18.1 · 12 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? (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
*	K971867	Alice 4R System Summary page 1 …mber: 2500 Classification Name: Programmable Diagnostic Computer, 21 CFR 870.1425 Device Classification: DQK Predicate Devices: Healthdyne Technologies’ Alice 4 System, K971867. Masimo SET MS-1 Pulse Oximeter and Accessories, K962603. Simon Multichannel Recording System, K983572. Device Description: Smar…	Healthdyne Technologies, Inc.	1997	—
*	K962603	Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables Summary page 1 …omputer, 21 CFR 870.1425 Device Classification: DQK Predicate Devices: Healthdyne Technologies’ Alice 4 System, K971867. Masimo SET MS-1 Pulse Oximeter and Accessories, K962603. Simon Multichannel Recording System, K983572. Device Description: SmartRecorder™ is a software-controlled device, which utilize…	Masimo Corp.	1997	—
*	K983572	Simon Multichannel Recording System, Model 5500 Cleared while this submission was under review Summary page 1 …: DQK Predicate Devices: Healthdyne Technologies’ Alice 4 System, K971867. Masimo SET MS-1 Pulse Oximeter and Accessories, K962603. Simon Multichannel Recording System, K983572. Device Description: SmartRecorder™ is a software-controlled device, which utilizes the same “engine” as Healthdyne Technologies…	Healthdyne Technologies, Inc.	1999	—

Also cleared against K971867: 3 other devices →

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 2 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
None of the 3 ancestors has a recall.
3 other devices also cite its predicate K971867.

How does its category compare?

All MNR devices

MNR Ventilatory Effort Recorder: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MNR

10in 2025

2007high 14 (2008) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNR

165in 2025

2007high 383 (2019) · low 89 (2009)2026

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

Recalls per year · MNR

1in 2021

2007high 2 (2007) · low 0 (2008)2026

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

Adverse event reports per year · MNR

43in 2025

2007high 43 (2025) · low 0 (2008)2025

MAUDE reports naming product code MNR, 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	6	124	2	1
2008	14	118	0	0
2009	8	89	1	0
2010	0	—	0	1
2011	9	90	1	1
2012	1	—	0	1
2013	4	161	0	0
2014	2	—	0	1
2015	4	229	0	4
2016	3	281	0	10
2017	4	275	0	4
2018	3	147	0	2
2019	8	383	0	3
2020	5	192	0	5
2021	3	137	1	5
2022	7	266	0	4
2023	6	183	0	13
2024	6	217	0	11
2025	10	165	0	43
2026	5	227	1	—

What is it indicated for?

The Respironics SmartRecorder is a multichannel recording system designed to record and store physiologic signals acquired from adult and infant patients during sleep. SmartRecorder is designed for use in the home or hospital. Physiological signals are acquired via transducers attached to the patient and directly connected to the recorder and/or monitoring or therapeutic device connected to the recorder. Use of the associated Synergy S (host) software…

Read the full statement (132 words)

Physiological signals are acquired via transducers attached to the patient and directly connected to the recorder and/or monitoring or therapeutic device connected to the recorder.

Use of the associated Synergy S (host) software facilitates retrieval of data recorded by SmartRecorder via direct PC connection; remotely via internal modem; or by transferring data directly from the removable PCMCIA memory card to a PC. Once downloaded, the recorded data can be analyzed for physiological events.

Synergy S allows the clinician can display, review, edit and print analyzed data as well as configure / customize all reports to best meet individual needs.

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/K990199 · printed Nov 4, 2026

Cite this page

510(k) Report. “K990199: Smartrecorder, Model 2500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990199

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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