510(k) · Cleared
ClearedZmachine Synergy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Consolidated Research of Richmond, Inc. Dba General Sleep CO · OLV Standard Polysomnograph With Electroencephalograph
Cleared on Dec 19, 2017 as substantially equivalent to K101830 (Consolidated Research of Richmond, Inc., 2011) and 1 other predicate after an 83-day review. Its family tree reaches back 10 generations to 1992. 2 later devices descend from it.
- Decided
- Dec 19, 2017
- Review
- 83 days
- Class
- Class II
- Product code
- OLV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K913396 (1992). 45 ancestors in all, the oldest K893221 (1990). 2 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 6 generations between
- 3 generations backK083575 Apnealink Plus, Model: 22328Resmed Germany, Inc. · 2009
- 2 generations backK131932 Apnealink ProResmed Germany, Inc. · 2013
- 1 generation backK143272 ApneaLink AirResmed Germany, Inc. · 2015
- This deviceK172986 Zmachine SynergyConsolidated Research of Richmond, Inc. Dba General Sleep CO · 2017
- Descendant · cites it directly · 0 of its ownK242447 Falcon HSTCompumedics Limited · 2025
- Descendant · cites it directly · 0 of its ownK192624 ApneaTrakCadwell Industries, Inc. · 2020
Show all 10 generations
- Root · 10 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 9 generations backK982293 Pressure Transducer Airflow SensorPro-Tech Services, Inc. · 1998
- 8 generations backK020607 Sleepflo, Model 101501Biomec, Inc. · 2002
- 7 generations backK030379 Aplab, Model 801D0030Sector Medical Corp. · 2003
- 6 generations backK040576 Micromesam Basic-SetMap Medizintechnik Fur Arzt Und Patient GmbH · 2004
- 5 generations backK061405 Apnealink, Model 22302Resmed Germany, Inc. · 2006
- 4 generations backK070263 ApnealinkResmed Germany, Inc. · 2007
- 3 generations backK083575 Apnealink Plus, Model: 22328Resmed Germany, Inc. · 2009
- 2 generations backK131932 Apnealink ProResmed Germany, Inc. · 2013
- 1 generation backK143272 ApneaLink AirResmed Germany, Inc. · 2015
- This deviceK172986 Zmachine SynergyConsolidated Research of Richmond, Inc. Dba General Sleep CO · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K913396 | Cannula Style Thermocouples | Pro-Tech, Inc. | 1992 | — |
| −9 | K982293 | Pressure Transducer Airflow Sensor | Pro-Tech Services, Inc. | 1998 | — |
| −8 | K020607 | Sleepflo, Model 101501 | Biomec, Inc. | 2002 | — |
| −7 | K030379 | Aplab, Model 801D0030 | Sector Medical Corp. | 2003 | — |
| −6 | K040576 | Micromesam Basic-Set | Map Medizintechnik Fur Arzt Und Patient GmbH | 2004 | — |
| −5 | K061405 | Apnealink, Model 22302 | Resmed Germany, Inc. | 2006 | — |
| −4 | K070263 | Apnealink | Resmed Germany, Inc. | 2007 | — |
| −3 | K083575 | Apnealink Plus, Model: 22328 | Resmed Germany, Inc. | 2009 | — |
| −2 | K131932 | Apnealink Pro | Resmed Germany, Inc. | 2013 | — |
| −1 | K143272 | ApneaLink Air | Resmed Germany, Inc. | 2015 | — |
| 0 (this device) | K172986 | Zmachine Synergy | Consolidated Research of Richmond, Inc. Dba General Sleep CO | 2017 | — |
| +1 | K242447 | Falcon HST | Compumedics Limited | 2025 | — |
| +1 | K192624 | ApneaTrak | Cadwell Industries, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 4 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 5 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2025 | 1 | 0 |
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 OLV? 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 OLV device
- #1 K241288 Noxturnal Webscore 17.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K101830 | Zmachine, Model DT-100Summary page 4…nvironment, under the direction of a qualified healthcare practitioner, to aid in the diagnosis of sleep disorders. Predicate Zmachine DT-100 (K101830) – primary Devices ApneaLink Air (K143272) Page 5-1 Dev… | 2011 |
| * | K143272 | ApneaLink AirSummary page 4…hcare practitioner, to aid in the diagnosis of sleep disorders. Predicate Zmachine DT-100 (K101830) – primary Devices ApneaLink Air (K143272) Page 5-1 Device Description The Zmachine Synergy system is a por… | 2015 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 25 years and passes through 7 companies; a new generation was cleared every 2.1 years on median.
- 4 of the 45 ancestors have a recall of any class.
- Of its descendants, K242447 (Compumedics Limited, 2025) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K101830.
How does its category compare?
All OLV devicesOLV Standard Polysomnograph With Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · OLV
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLV
141in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLV
No recall names OLV since 2007.
Adverse event reports per year · OLV
1in 2025
MAUDE reports naming product code OLV, 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 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 3 | 83 | 0 | 0 |
| 2018 | 3 | 141 | 0 | 3 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 2 | — | 0 | 2 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Zmachine Synergy is an EEG and respiratory signal recorder. The device is intended for use by adult patients in the home or clinical environment, under the direction of a qualified healthcare practitioner, to aid in the diagnosis of sleep disorders.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172986 · printed Nov 4, 2026
Cite this page
510(k) Report. “K172986: Zmachine Synergy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K172986
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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