510(k) · Cleared
ClearedForesee Home
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Notal Vision, Ltd. · HPT Perimeter, Automatic, Ac-Powered
Cleared on Dec 23, 2009 as substantially equivalent to K050350 (Notal Vision, Inc., 2005) and 3 other predicates after a 204-day review. Its family tree reaches back 9 generations to 1987. 4 later devices descend from it.
- Decided
- Dec 23, 2009
- Review
- 204 days
- Class
- Class I
- Product code
- HPT
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K864318 (1987). 38 ancestors in all, the oldest K790130 (1979). 4 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 5 generations between
- 3 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 2 generations backK051470 Remote Care Management Systems (RCMS)Bl Healthcare, Inc. · 2005
- 1 generation backK071564 Motiva Monitor Device Connectivity, Model# 453564036921Philips Medical Systems · 2007
- This deviceK091579 Foresee HomeNotal Vision, Ltd. · 2009
- Descendant · cites it directly · 3 of its ownK121738 Myvisiontrack (TM)Vital Art and Science Incorporated · 2013
- Descendant · 2 generations on · 2 of its ownK143211 myVision Track Model 005Vital Art and Science Incorporated · 2015
- Descendant · 3 generations on · 1 of its ownK180895 AlleyeOculocare Medical AG · 2018
- Descendant · 4 generations on · 0 of its ownK203594 EyeCTesterNeuro-Eye Diagnostic Systems, LLC · 2022
Show all 9 generations
- Root · 9 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 8 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 7 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 6 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 5 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 4 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- 3 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 2 generations backK051470 Remote Care Management Systems (RCMS)Bl Healthcare, Inc. · 2005
- 1 generation backK071564 Motiva Monitor Device Connectivity, Model# 453564036921Philips Medical Systems · 2007
- This deviceK091579 Foresee HomeNotal Vision, Ltd. · 2009
Most influential descendants
Showing 4 of 4 · See all- K121738Myvisiontrack (TM)Vital Art and Science Incorporated · 2013 · cites it directly3descendants
- K143211myVision Track Model 005Vital Art and Science Incorporated · 2015 · 2 generations on2descendants
- K180895AlleyeOculocare Medical AG · 2018 · 3 generations on1descendant
- K203594EyeCTesterNeuro-Eye Diagnostic Systems, LLC · 2022 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −8 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −7 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −6 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −5 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −4 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| −3 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| −2 | K051470 | Remote Care Management Systems (RCMS) | Bl Healthcare, Inc. | 2005 | — |
| −1 | K071564 | Motiva Monitor Device Connectivity, Model# 453564036921 | Philips Medical Systems | 2007 | — |
| 0 (this device) | K091579 | Foresee Home | Notal Vision, Ltd. | 2009 | — |
| +1 | K121738 | Myvisiontrack (TM) | Vital Art and Science Incorporated | 2013 | — |
| +2 | K143211 | myVision Track Model 005 | Vital Art and Science Incorporated | 2015 | — |
| +3 | K180895 | Alleye | Oculocare Medical AG | 2018 | — |
| +4 | K203594 | EyeCTester | Neuro-Eye Diagnostic Systems, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1984 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 5 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 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 HPT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K050350 | The Notal Vision Preview Preferential Hyperacuity Perimeter (Preview PHP)Summary page 1…perimeter NAME: DEVICE Class | CLASSIFICATION: PropucT CODE: HPT PREDICATE Preview PHP™ DEVICE: SUBSTANTIALLY EQUIVALENT TO: 510K TRADE OR PROPRIETARY NAME MANUFACTURER K050350 | Preview PHP™ Notal Vision Ltd. K063609 | River 1 SHL Telemedicine International, Ltd. NA Amsler Grid Chart NA K053303 | Command… | 2005 |
| * | K063609 | River- 1 Electrocardiograph (Ecg) Recorder and TransmitterSummary page 1…ATION: PropucT CODE: HPT PREDICATE Preview PHP™ DEVICE: SUBSTANTIALLY EQUIVALENT TO: 510K TRADE OR PROPRIETARY NAME MANUFACTURER K050350 | Preview PHP™ Notal Vision Ltd. K063609 | River 1 SHL Telemedicine International, Ltd. NA Amsler Grid Chart NA K053303 | Commander III Cardiocom K071564 | Motiva Philips… | 2007 |
| * | K053303 | Cardiocom Commander IiiSummary page 1…T TO: 510K TRADE OR PROPRIETARY NAME MANUFACTURER K050350 | Preview PHP™ Notal Vision Ltd. K063609 | River 1 SHL Telemedicine International, Ltd. NA Amsler Grid Chart NA K053303 | Commander III Cardiocom K071564 | Motiva Philips Medical Systems DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION… | 2005 |
| * | K071564 | Motiva Monitor Device Connectivity, Model# 453564036921Summary page 1…ME MANUFACTURER K050350 | Preview PHP™ Notal Vision Ltd. K063609 | River 1 SHL Telemedicine International, Ltd. NA Amsler Grid Chart NA K053303 | Commander III Cardiocom K071564 | Motiva Philips Medical Systems DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION The Foresee Home system is an inte… | 2007 |
| * | — | Amsler Grid Chart Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121738 | Myvisiontrack (TM) | 2013 | 3 |
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 22 years and passes through 8 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 38 ancestors have a recall of any class.
- Of its descendants, K121738 (Vital Art and Science Incorporated, 2013) has gone furthest, with 3 descendants of its own.
How does its category compare?
All HPT devicesHPT Perimeter, Automatic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · HPT
2in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · HPT
Too few HPT 510(k)s in any year since 2007 to give a median.
Recalls per year · HPT
No recall names HPT since 2007.
Adverse event reports per year · HPT
1in 2023
MAUDE reports naming product code HPT, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Foresce Home is intended for use in the detection and characterization of central and paracentral metamorphopsia (visual distortion) in patients with age-related macular degeneration, as an aid in monitoring progression of disease factors causing metamorphopsia including but not limited to choroidal neovascularization (CNV). It is intended to be used at home for patients with stable fixation.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K091579 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091579: Foresee Home.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091579
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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