510(k) · Cleared
ClearedIdeal Life Pod (Model Ilp 0001)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ideal Life, Inc. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Jul 3, 2008 as substantially equivalent to K984527 (Lifescan, Inc., 1999) and 1 other predicate after a 128-day review. Its family tree reaches back 7 generations to 1987. 4 later devices descend from it.
- Decided
- Jul 3, 2008
- Review
- 128 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K864318 (1987). 18 ancestors in all, the oldest K790130 (1979). 4 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 6 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 5 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 4 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 3 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 2 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- 1 generation backK060504 Ideal Life BP-Manager, Model BPM 0001; Ideal Life Pod, Model Ilp 0001Ideal Life, Inc. · 2006
- This deviceK080538 Ideal Life Pod (Model Ilp 0001)Ideal Life, Inc. · 2008
- Descendant · cites it directly · 2 of its ownK111932 Iglucose SystemPositiveid Corporation · 2011
- Descendant · 2 generations on · 1 of its ownK130676 Ambio Remote Health Monitoring SystemArrayent Health, LLC D/B/A Ambio Health · 2013
- Descendant · 3 generations on · 0 of its ownK132148 S HealthSamsung Electronics Co., Ltd. · 2013
- Descendant · cites it directly · 0 of its ownK100524 Polytel (R) Apt Model: Pwa-08-01Polymap Wireless, LLC · 2010
Most influential descendants
Showing 4 of 4 · See all- K111932Iglucose SystemPositiveid Corporation · 2011 · cites it directly2descendants
- K130676Ambio Remote Health Monitoring SystemArrayent Health, LLC D/B/A Ambio Health · 2013 · 2 generations on1descendant
- K132148S HealthSamsung Electronics Co., Ltd. · 2013 · 3 generations on0descendants
- K100524Polytel (R) Apt Model: Pwa-08-01Polymap Wireless, LLC · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −6 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −5 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −4 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −3 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −2 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| −1 | K060504 | Ideal Life BP-Manager, Model BPM 0001; Ideal Life Pod, Model Ilp 0001 | Ideal Life, Inc. | 2006 | — |
| 0 (this device) | K080538 | Ideal Life Pod (Model Ilp 0001) | Ideal Life, Inc. | 2008 | — |
| +1 | K111932 | Iglucose System | Positiveid Corporation | 2011 | — |
| +2 | K130676 | Ambio Remote Health Monitoring System | Arrayent Health, LLC D/B/A Ambio Health | 2013 | — |
| +3 | K132148 | S Health | Samsung Electronics Co., Ltd. | 2013 | — |
| +1 | K100524 | Polytel (R) Apt Model: Pwa-08-01 | Polymap Wireless, LLC | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 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 NBW? 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 NBW device
- #1 K260545 CONTOUR® PLUS BLUE Blood Glucose Monitoring…score 14.6 · 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 |
|---|---|---|---|
| * | K984527 | IN Touch Diabetes Management SoftwareSummary page 1…e: 416.489.1494, Ext 200 Fax: 416.489.3009 Date Prepared: February 15, 2008 A. LEGALLY MARKETED PREDICATE DEVICES K984527, In Touch Diabetes Management Software, Lifescan, Inc. K060504, IDEAL LIFE Pod, IDEAL LIFE INC. B. DEVICE DESCRIPTION The… | 1999 |
| * | K060504 | Ideal Life BP-Manager, Model BPM 0001; Ideal Life Pod, Model Ilp 0001Summary page 1…416.489.3009 Date Prepared: February 15, 2008 A. LEGALLY MARKETED PREDICATE DEVICES K984527, In Touch Diabetes Management Software, Lifescan, Inc. K060504, IDEAL LIFE Pod, IDEAL LIFE INC. B. DEVICE DESCRIPTION The IDEAL LIFE Pod is a simple, user-friendly wireless modem access… | 2006 |
What descends from it? (4)
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 21 years and passes through 7 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 18 ancestors has a recall of any class.
- Of its descendants, K111932 (Positiveid Corporation, 2011) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K984527.
How does its category compare?
All NBW devicesNBW System, Test, Blood Glucose, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · NBW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NBW
243in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NBW
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · NBW
4,745in 2025
MAUDE reports naming product code NBW, 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 | 29 | 85 | 9 | 7,991 |
| 2008 | 37 | 128 | 2 | 7,704 |
| 2009 | 38 | 140 | 5 | 10,963 |
| 2010 | 31 | 132 | 11 | 11,631 |
| 2011 | 30 | 328 | 1 | 22,909 |
| 2012 | 30 | 230 | 1 | 23,449 |
| 2013 | 47 | 167 | 5 (2) | 35,408 |
| 2014 | 24 | 202 | 1 | 38,524 |
| 2015 | 32 | 237 | 0 | 62,111 |
| 2016 | 20 | 233 | 1 | 76,621 |
| 2017 | 25 | 244 | 0 | 37,538 |
| 2018 | 19 | 168 | 0 | 16,911 |
| 2019 | 10 | 127 | 14 | 14,472 |
| 2020 | 7 | 121 | 0 | 10,703 |
| 2021 | 7 | 465 | 0 | 9,198 |
| 2022 | 12 | 410 | 0 | 8,103 |
| 2023 | 5 | 193 | 0 | 7,256 |
| 2024 | 7 | 243 | 0 | 6,220 |
| 2025 | 2 | — | 1 | 4,745 |
| 2026 | 5 | 190 | 0 | — |
What is it indicated for?
The IDEAL LIFE PodTM receives data wirelessly from IDEAL LIFE devices to transmit over the Internet or common telephone lines from the user's home. The Pod is an optional accessory to IDEAL LIFE devices, including the GlucoManagerTM, the BP-ManagerTM and/or the Body ManagerTM. The Pod is intended to aid people at home and health care professionals to review and evaluate historical blood glucose, weight and blood pressure test results, to support effective health care management.
The IDEAL LIFE Pod makes no interpretation, evaluation, medical judgment or recommendations for treatment. This device is not intended as a substitute for medical care.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080538 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080538: Ideal Life Pod (Model Ilp 0001).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080538
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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