510(k) Report

510(k) · Cleared

Cleared

Maestro Clinical Remote Control

K954572510(k) TraditionalCleared Jun 26, 1996268-day reviewClass II21 CFR 868.5905

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

Respironics, Inc. · BZD Ventilator, Non-Continuous (Respirator)

Cleared on Jun 26, 1996 as substantially equivalent to K910194 (Puritan Bennett Corp., 1991) and 1 other predicate after a 268-day review. Its family tree reaches back 1 generation to 1991.

Decided
Jun 26, 1996
Review
268 days
Class
Class II
Product code
BZD
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K910194 (1991). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1992: 1 other ancestorK910194 · Companion 318 Nasal Cpap Diagnostics System · Puritan Bennett Corp. · 199119901992199419961998
Other ancestors, by generation 1 generation back: 1 other ancestor K910194 · Companion 318 Nasal Cpap Diagnostics System · Puritan Bennett Corp. · 19910
  1. Root · 1 generation backK910194 Companion 318 Nasal Cpap Diagnostics SystemPuritan Bennett Corp. · 1991
  2. This deviceK954572 Maestro Clinical Remote ControlRespironics, Inc. · 1996
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K910194Companion 318 Nasal Cpap Diagnostics SystemPuritan Bennett Corp.1991—
0 (this device)K954572Maestro Clinical Remote ControlRespironics, Inc.1996—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
FIG. 1 — Lineage of K954572, 1991–1996Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 BZD? 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 BZD device

  1. #1 K250624 myAirscore 15.7 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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.

TypeNumberDeviceApplicantDecidedRecalls
*K910194Companion 318 Nasal Cpap Diagnostics System
Summary page 1
…Noncontinuous Ventilator Common/Usual Name Remote Control Proprietary Name Maestro Clinical Remote Control Puritan-Bennett Companion 318 Nasal CPAP Diagnostics System (K910194) Predicate Device Respironics' REMstar Choice Clinical Remote Control (K920699) Predicate Device Information The technologica…
Puritan Bennett Corp.1991—
*K920699Remstar Wtih Ramp and Remote Modification
Summary page 1
…ro Clinical Remote Control Puritan-Bennett Companion 318 Nasal CPAP Diagnostics System (K910194) Predicate Device Respironics' REMstar Choice Clinical Remote Control (K920699) Predicate Device Information The technological characteristics of the Maestro Clinical Remote Control (CRC) are substantially…
Respironics, Inc.1992—

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 BZD devices

BZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BZD

7in 2025

2007: 212008: 172009: 232010: 122011: 232012: 212013: 232014: 142015: 112016: 122017: 52018: 52019: 62020: 62021: 62022: 42023: 52024: 102025: 72026 (partial year): 10
2007high 23 (2009) · low 4 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BZD

189in 2025

2007: 83 days median2008: 108 days median2009: 90 days median2010: 122 days median2011: 125 days median2012: 133 days median2013: 127 days median2014: 172 days median2015: 224 days median2016: 217 days median2017: 221 days median2018: 280 days median2019: 231 days median2020: 137 days median2021: 192 days median2022: 253 days median2023: 204 days median2024: 132 days median2025: 189 days median2026 (partial year): 214 days median
2007high 280 (2018) · low 83 (2007)2026

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

Recalls per year · BZD

8in 2023

2007: 292008: 22009: 12011: 12019: 4, 4 Class I2023: 8, 7 Class I2026 (partial year): 2, 2 Class I
2007high 29 (2007) · low 0 (2010)2026

Class I (13 since 2007) Class II/III not classified

Adverse event reports per year · BZD

60,279in 2025

2007: 652008: 672009: 1472010: 1432011: 1892012: 1392013: 822014: 862015: 1142016: 1182017: 1482018: 1012019: 1882020: 1262021: 6,0662022: 90,7682023: 27,9872024: 68,2622025: 60,279
2007high 90,768 (2022) · low 65 (2007)2025

MAUDE reports naming product code BZD, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200721832965
200817108267
200923901147
2010121220143
2011231251189
2012211330139
201323127082
201414172086
2015112240114
2016122170118
201752210148
201852800101
201962314 (4)188
202061370126
2021619206,066
20224253090,768
202352048 (7)27,987
202410132068,262
20257189060,279
2026102142 (2)—

What is it indicated for?

The Maestro CRC is an optional accessory that provides remote control capabilities when used in conjunction with Respironics Aria CPAP and Virtuoso Smart CPAP Systems and is intended for use by a qualified clinician (any individual trained to perform sleep study diagnoses) in hospital/sleep laboratory settings where adult patients suffering from OSA are diagnosed and treated.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

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The BZD category page

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https://510kreport.com/device/K954572 · printed Nov 4, 2026

Cite this page

510(k) Report. “K954572: Maestro Clinical Remote Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954572

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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