510(k) · Cleared
ClearedFalcon HST
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Compumedics Limited · OLV Standard Polysomnograph With Electroencephalograph
Cleared on Feb 20, 2025 as substantially equivalent to K172986 (Consolidated Research of Richmond, Inc. Dba General Sleep CO, 2017) and 1 other predicate after a 188-day review. Its family tree reaches back 11 generations to 1992.
- Decided
- Feb 20, 2025
- Review
- 188 days
- Class
- Class II
- Product code
- OLV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K913396 (1992). 46 ancestors in all, the oldest K893221 (1990). No later device cites it as a predicate yet.
- Root · 11 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 7 generations between
- 3 generations backK131932 Apnealink ProResmed Germany, Inc. · 2013
- 2 generations backK143272 ApneaLink AirResmed Germany, Inc. · 2015
- 1 generation backK172986 Zmachine SynergyConsolidated Research of Richmond, Inc. Dba General Sleep CO · 2017
- This deviceK242447 Falcon HSTCompumedics Limited · 2025
Show all 11 generations
- Root · 11 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 10 generations backK982293 Pressure Transducer Airflow SensorPro-Tech Services, Inc. · 1998
- 9 generations backK020607 Sleepflo, Model 101501Biomec, Inc. · 2002
- 8 generations backK030379 Aplab, Model 801D0030Sector Medical Corp. · 2003
- 7 generations backK040576 Micromesam Basic-SetMap Medizintechnik Fur Arzt Und Patient GmbH · 2004
- 6 generations backK061405 Apnealink, Model 22302Resmed Germany, Inc. · 2006
- 5 generations backK070263 ApnealinkResmed Germany, Inc. · 2007
- 4 generations backK083575 Apnealink Plus, Model: 22328Resmed Germany, Inc. · 2009
- 3 generations backK131932 Apnealink ProResmed Germany, Inc. · 2013
- 2 generations backK143272 ApneaLink AirResmed Germany, Inc. · 2015
- 1 generation backK172986 Zmachine SynergyConsolidated Research of Richmond, Inc. Dba General Sleep CO · 2017
- This deviceK242447 Falcon HSTCompumedics Limited · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K913396 | Cannula Style Thermocouples | Pro-Tech, Inc. | 1992 | — |
| −10 | K982293 | Pressure Transducer Airflow Sensor | Pro-Tech Services, Inc. | 1998 | — |
| −9 | K020607 | Sleepflo, Model 101501 | Biomec, Inc. | 2002 | — |
| −8 | K030379 | Aplab, Model 801D0030 | Sector Medical Corp. | 2003 | — |
| −7 | K040576 | Micromesam Basic-Set | Map Medizintechnik Fur Arzt Und Patient GmbH | 2004 | — |
| −6 | K061405 | Apnealink, Model 22302 | Resmed Germany, Inc. | 2006 | — |
| −5 | K070263 | Apnealink | Resmed Germany, Inc. | 2007 | — |
| −4 | K083575 | Apnealink Plus, Model: 22328 | Resmed Germany, Inc. | 2009 | — |
| −3 | K131932 | Apnealink Pro | Resmed Germany, Inc. | 2013 | — |
| −2 | K143272 | ApneaLink Air | Resmed Germany, Inc. | 2015 | — |
| −1 | K172986 | Zmachine Synergy | Consolidated Research of Richmond, Inc. Dba General Sleep CO | 2017 | — |
| 0 (this device) | K242447 | Falcon HST | Compumedics Limited | 2025 | — |
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 |
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 |
|---|---|---|---|
| * | K172986 | Zmachine SynergySummary page 5…Device Information Primary Predicate Device: Trade Name: Zmachine Synergy Manufacturer: Consolidated Research of Richmond, Inc. 510(k) number: K172986 510(k) Decision Date: 19th Dec 2017 Classification: Electroencephalograph Product code: OLV, OMC, MNR Device class:… | 2017 |
| * | K101830 | Zmachine, Model DT-100Summary page 5…s: 21 CFR 882.1400 Secondary Predicate Device: Trade Name: Zmachine DT-100 Manufacturer: Consolidated Research of Richmond, Inc. 510(k) number: K101830 510(k) Decision Date: 31st Mar 2011 Classification: Electroencephalograph Product code: OLV, OMC Device class:… | 2011 |
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 33 years and passes through 8 companies; a new generation was cleared every 2.1 years on median.
- 4 of the 46 ancestors have a recall of any class.
- 1 other device also cites its predicate K172986.
How does its category compare?
All OLV devicesOLV Standard Polysomnograph With Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Falcon HST 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/K242447 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242447: Falcon HST.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242447
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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