510(k) · Cleared
ClearedPolytel Gma, Models PWR-08-67, PWR-08-07, PWR-08-09
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Polymap Wireless · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Jul 17, 2009 as substantially equivalent to K070559 (Polymap Wireless, 2007) and 1 other predicate after a 74-day review. Its family tree reaches back 8 generations to 1987.
- Decided
- Jul 17, 2009
- Review
- 74 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K864318 (1987). 16 ancestors in all, the oldest K790130 (1979). No later device cites it as a predicate yet.
- Root · 8 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 7 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 6 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 5 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 4 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 3 generations backK041816 RTX3320PSTN Wireless Telehealth GatewayRtx Healthcare A/S · 2004
- 2 generations backK052343 E-San Bluetooth CradleE-San Limited · 2005
- 1 generation backK061328 Think Positive Diabetes Management System (T+Diabetes System)E-San Limited · 2006
- This deviceK091296 Polytel Gma, Models PWR-08-67, PWR-08-07, PWR-08-09Polymap Wireless · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −7 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −6 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −5 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −4 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −3 | K041816 | RTX3320PSTN Wireless Telehealth Gateway | Rtx Healthcare A/S | 2004 | — |
| −2 | K052343 | E-San Bluetooth Cradle | E-San Limited | 2005 | — |
| −1 | K061328 | Think Positive Diabetes Management System (T+Diabetes System) | E-San Limited | 2006 | — |
| 0 (this device) | K091296 | Polytel Gma, Models PWR-08-67, PWR-08-07, PWR-08-09 | Polymap Wireless | 2009 | — |
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 |
| 2007 | 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 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 |
|---|---|---|---|
| * | K070559 | Polymap PWR-08-03Summary page 2…the information delivered. D. Substantial Equivalence Summary The Polytel GMA has the same fundamental scientific technology and intended use as the predicate devices (K070559 and K061328).. E. Technological Characteristics The Polytel GMA has technological characteristics that are very similar to thos… | 2007 |
| * | K061328 | Think Positive Diabetes Management System (T+Diabetes System)Summary page 2…ion delivered. D. Substantial Equivalence Summary The Polytel GMA has the same fundamental scientific technology and intended use as the predicate devices (K070559 and K061328).. E. Technological Characteristics The Polytel GMA has technological characteristics that are very similar to those of the pre… | 2006 |
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 22 years and passes through 8 companies; a new generation was cleared every 2.4 years on median.
- None of the 16 ancestors has a recall.
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. 2009, 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 Polytel GMA (models PWR-08-06, PWR-08-07, and PWR-08-09) are remote communications link devices intended to be used to wirelessly transmit glucose meter readings from a compatible Blood Glucose Monitor to a compatible cellular phone, such as the Nokia N73 or access point, such as the Polytel® APT. The receiving device, in turn, sends the readings to the healthcare provider in another location. The device does not send any real-time alarms. Clinical judgment and experience are required to check and interpret the information delivered.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091296 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091296: Polytel Gma, Models PWR-08-67, PWR-08-07, PWR-08-09.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091296
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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