510(k) · Cleared
ClearedInfosend GSM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fisher & Paykel Healthcare, Ltd. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Aug 19, 2011 as substantially equivalent to K081029 (Fisher & Paykel Healthcare, Ltd., 2008) and 1 other predicate after a 197-day review. Its family tree reaches back 13 generations to 1987. 1 later device descends from it.
- Decided
- Aug 19, 2011
- Review
- 197 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K864318 (1987). 69 ancestors in all, the oldest K790130 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 13 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 9 generations between
- 3 generations backK063612 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- 2 generations backK080798 Intel Health Guide, Model: PHS6000Intel Corp. · 2008
- 1 generation backK083862 Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2009
- This deviceK110316 Infosend GSMFisher & Paykel Healthcare, Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK161686 F&P InfoSmartFisher & Paykel Healthcare, Ltd. · 2017
Show all 13 generations
- Root · 13 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 12 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 11 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 10 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 9 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 8 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- 7 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 6 generations backK042273 Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004
- 5 generations backK050567 Health Buddy ApplianceHealth Hero Network, Inc. · 2005
- 4 generations backK060843 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- 3 generations backK063612 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- 2 generations backK080798 Intel Health Guide, Model: PHS6000Intel Corp. · 2008
- 1 generation backK083862 Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2009
- This deviceK110316 Infosend GSMFisher & Paykel Healthcare, Ltd. · 2011
Most influential descendants
Showing 1 of 1 · See all- K161686F&P InfoSmartFisher & Paykel Healthcare, Ltd. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −12 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −11 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −10 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −9 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −8 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| −7 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| −6 | K042273 | Modification to Health Buddy with Device Connectivity | Health Hero Network, Inc. | 2004 | — |
| −5 | K050567 | Health Buddy Appliance | Health Hero Network, Inc. | 2005 | — |
| −4 | K060843 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
| −3 | K063612 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
| −2 | K080798 | Intel Health Guide, Model: PHS6000 | Intel Corp. | 2008 | — |
| −1 | K083862 | Medapps 2.0 Remote Patient Monitoring System | Medapps, Inc. | 2009 | — |
| 0 (this device) | K110316 | Infosend GSM | Fisher & Paykel Healthcare, Ltd. | 2011 | — |
| +1 | K161686 | F&P InfoSmart | Fisher & Paykel Healthcare, Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 5 | 0 |
| 1999 | 5 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 6 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 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 K250624 myAirscore 15.7 · 12 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 |
|---|---|---|---|
| * | K081029 | Sleepstyle 200 Auto Series HC254Summary page 1…Anesthesiology Devices 21 CFR §868.5905 Class 11,BZD (a)(3) Identification of Legally Marketed Devices K081029 SleepStyle 200 Auto Series HC254 Fisher & Paykel Healthcare Ltd K083862 MedlApps 2.0 Remote Patient M… | 2008 |
| * | K083862 | Medapps 2.0 Remote Patient Monitoring SystemSummary page 1…Class 11,BZD (a)(3) Identification of Legally Marketed Devices K081029 SleepStyle 200 Auto Series HC254 Fisher & Paykel Healthcare Ltd K083862 MedlApps 2.0 Remote Patient Monitoring System MedApps Inc (a)(4) Description of the Device The lnfoGSM isan accessor… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161686 | F&P InfoSmart | 2017 | 0 |
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 24 years and passes through 10 companies; a new generation was cleared every 12 months on median.
- 6 of the 69 ancestors have a recall of any class.
- Of its descendants, K161686 (Fisher & Paykel Healthcare, Ltd., 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K081029.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · BZD
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BZD
189in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZD
8in 2023
Class I (13 since 2007) Class II/III not classified
Adverse event reports per year · BZD
60,279in 2025
MAUDE reports naming product code BZD, 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 | 21 | 83 | 29 | 65 |
| 2008 | 17 | 108 | 2 | 67 |
| 2009 | 23 | 90 | 1 | 147 |
| 2010 | 12 | 122 | 0 | 143 |
| 2011 | 23 | 125 | 1 | 189 |
| 2012 | 21 | 133 | 0 | 139 |
| 2013 | 23 | 127 | 0 | 82 |
| 2014 | 14 | 172 | 0 | 86 |
| 2015 | 11 | 224 | 0 | 114 |
| 2016 | 12 | 217 | 0 | 118 |
| 2017 | 5 | 221 | 0 | 148 |
| 2018 | 5 | 280 | 0 | 101 |
| 2019 | 6 | 231 | 4 (4) | 188 |
| 2020 | 6 | 137 | 0 | 126 |
| 2021 | 6 | 192 | 0 | 6,066 |
| 2022 | 4 | 253 | 0 | 90,768 |
| 2023 | 5 | 204 | 8 (7) | 27,987 |
| 2024 | 10 | 132 | 0 | 68,262 |
| 2025 | 7 | 189 | 0 | 60,279 |
| 2026 | 10 | 214 | 2 (2) | — |
What is it indicated for?
The F&P InfoGSM is intended for home and clinical use as an accessory for the F&P ICON CPAP device. The F&P InfoGSM transmits patient compliance and efficacy data from the CPAP device and allows this data to be reviewed by a clinician. In addition, remote adjustment of CPAP device settings is possible. The InfoGSM is intended for use with F&P Healthcare ICON CPAP devices only and should not be connected to any other device. The F&P InfoGSM is intended…
Read the full statement (148 words)
The F&P InfoGSM is intended for home and clinical use as an accessory for the F&P ICON CPAP device. The F&P InfoGSM transmits patient compliance and efficacy data from the CPAP device and allows this data to be reviewed by a clinician. In addition, remote adjustment of CPAP device settings is possible.
The InfoGSM is intended for use with F&P Healthcare ICON CPAP devices only and should not be connected to any other device.
The F&P InfoGSM is intended for home and clinical use as an accessory for the F&P ICON CPAP device. The F&P InfoGSM transmits patient compliance and efficacy data from the CPAP device and allows this data to be reviewed by a clinician. In addition, remote adjustment of CPAP device settings is possible.
The InfoGSM is intended for use with F&P Healthcare ICON CPAP devices only and should not be connected to any other device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110316 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110316: Infosend GSM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110316
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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