510(k) · Cleared
ClearedF&P InfoSmart
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 Jan 24, 2017 as substantially equivalent to K110316 (Fisher & Paykel Healthcare, Ltd., 2011) after a 221-day review. Its family tree reaches back 14 generations to 1987.
- Decided
- Jan 24, 2017
- Review
- 221 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K864318 (1987). 70 ancestors in all, the oldest K790130 (1979). No later device cites it as a predicate yet.
- Root · 14 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 10 generations between
- 3 generations backK080798 Intel Health Guide, Model: PHS6000Intel Corp. · 2008
- 2 generations backK083862 Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2009
- 1 generation backK110316 Infosend GSMFisher & Paykel Healthcare, Ltd. · 2011
- This deviceK161686 F&P InfoSmartFisher & Paykel Healthcare, Ltd. · 2017
Show all 14 generations
- Root · 14 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 13 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 12 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 11 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 10 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 9 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- 8 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 7 generations backK042273 Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004
- 6 generations backK050567 Health Buddy ApplianceHealth Hero Network, Inc. · 2005
- 5 generations backK060843 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- 4 generations backK063612 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- 3 generations backK080798 Intel Health Guide, Model: PHS6000Intel Corp. · 2008
- 2 generations backK083862 Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2009
- 1 generation backK110316 Infosend GSMFisher & Paykel Healthcare, Ltd. · 2011
- This deviceK161686 F&P InfoSmartFisher & Paykel Healthcare, Ltd. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −13 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −12 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −11 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −10 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −9 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| −8 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| −7 | K042273 | Modification to Health Buddy with Device Connectivity | Health Hero Network, Inc. | 2004 | — |
| −6 | K050567 | Health Buddy Appliance | Health Hero Network, Inc. | 2005 | — |
| −5 | K060843 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
| −4 | K063612 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
| −3 | K080798 | Intel Health Guide, Model: PHS6000 | Intel Corp. | 2008 | — |
| −2 | K083862 | Medapps 2.0 Remote Patient Monitoring System | Medapps, Inc. | 2009 | — |
| −1 | K110316 | Infosend GSM | Fisher & Paykel Healthcare, Ltd. | 2011 | — |
| 0 (this device) | 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 |
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? (1)
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 |
|---|---|---|---|
| * | K110316 | Infosend GSMSummary page 4…) Class II (21 CFR §868.5905) Product code BZD (Anaesthesiology) Predicate device InfoGSM (K110316) Device Description InfoSmart™ is a software reporting tool which provides reports on sleep therapy data including compl… | 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 30 years and passes through 10 companies; a new generation was cleared every 1.0 years on median.
- 6 of the 70 ancestors have a recall of any class.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
InfoSmart™ is a software application for use with compatible Fisher & Paykel Healthcare OSA Flow generators. It allows for remote collection and management of device usage and therapeutic information. It also allows for remote therapy reporting and adjustment of device settings by a clinician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161686 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161686: F&P InfoSmart.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161686
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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