510(k) · Cleared
ClearedQuadra Bloc Tens Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gradient Technologies, LLC · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Oct 20, 2011 as substantially equivalent to K062547 (Gradient Technologies, LLC, 2007) and 2 other predicates after a 435-day review. Its family tree reaches back 7 generations to 2000.
- Decided
- Oct 20, 2011
- Review
- 435 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K001179 (2000). 27 ancestors in all, the oldest K871222 (1987). No later device cites it as a predicate yet.
- Root · 7 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 6 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- 5 generations backK032816 Quantum Light Therapy SystemStargate International, Inc. · 2004
- 4 generations backK041530 Excalibur Light Therapy System, Model Sgiex-04-001Stargate International, Inc. · 2004
- 3 generations backK050668 GRT Lite, Model 8-aGrt Solutions, Inc. · 2006
- 2 generations backK081141 Combocare 2000Xanacare Technologies, LLC · 2008
- 1 generation backK083202 Combocare 2000Xanacare Technologies, LLC · 2008
- This deviceK102278 Quadra Bloc Tens PlusGradient Technologies, LLC · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −6 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| −5 | K032816 | Quantum Light Therapy System | Stargate International, Inc. | 2004 | — |
| −4 | K041530 | Excalibur Light Therapy System, Model Sgiex-04-001 | Stargate International, Inc. | 2004 | — |
| −3 | K050668 | GRT Lite, Model 8-a | Grt Solutions, Inc. | 2006 | — |
| −2 | K081141 | Combocare 2000 | Xanacare Technologies, LLC | 2008 | — |
| −1 | K083202 | Combocare 2000 | Xanacare Technologies, LLC | 2008 | — |
| 0 (this device) | K102278 | Quadra Bloc Tens Plus | Gradient Technologies, LLC | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 5 | 0 |
| 2005 | 1 | 0 |
| 2007 | 4 | 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 GZJ? 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 GZJ device
- #1 K252767 actiTENS miniscore 13.1 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K062547 | Quadra Bloc Tens, Model 101Summary page 1…Classification Name: Transcutaneous electrical nerve stimulator, for pan relief Product Code: GZJ C. Predicate Devices i. The Quadra Bloc TENS, Model 101 -K062547 ii. ComboCare 2000- K083202 iii. Pepin Manufacturing Inc electrode - K070807 The current QuadraBloc TENS Model 101… | 2007 |
| * | K083202 | Combocare 2000Summary page 1…electrical nerve stimulator, for pan relief Product Code: GZJ C. Predicate Devices i. The Quadra Bloc TENS, Model 101 -K062547 ii. ComboCare 2000- K083202 iii. Pepin Manufacturing Inc electrode - K070807 The current QuadraBloc TENS Model 101 is identical to the original Quadra… | 2008 |
| * | K070807 | Cutaneous Electrotherapy and Recording Electrodes; Tens ElectrodesSummary page 1…uct Code: GZJ C. Predicate Devices i. The Quadra Bloc TENS, Model 101 -K062547 ii. ComboCare 2000- K083202 iii. Pepin Manufacturing Inc electrode - K070807 The current QuadraBloc TENS Model 101 is identical to the original QuadraBloc TENS Model 101; the modification to the QuadraBloc… | 2007 |
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 11 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 1 of the 27 ancestors has a recall of any class.
How does its category compare?
All GZJ devicesGZJ Stimulator, Nerve, Transcutaneous, For Pain Relief: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · GZJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GZJ
207in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GZJ
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GZJ
13in 2025
MAUDE reports naming product code GZJ, 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 | 13 | 223 | 4 | 4 |
| 2008 | 11 | 136 | 1 | 45 |
| 2009 | 16 | 155 | 0 | 17 |
| 2010 | 5 | 232 | 0 | 22 |
| 2011 | 5 | 168 | 1 | 22 |
| 2012 | 12 | 154 | 0 | 20 |
| 2013 | 2 | — | 0 | 10 |
| 2014 | 4 | 344 | 0 | 23 |
| 2015 | 3 | 202 | 0 | 18 |
| 2016 | 3 | 163 | 0 | 32 |
| 2017 | 3 | 113 | 0 | 58 |
| 2018 | 2 | — | 0 | 21 |
| 2019 | 3 | 156 | 0 | 7 |
| 2020 | 4 | 183 | 0 | 10 |
| 2021 | 3 | 231 | 0 | 5 |
| 2022 | 4 | 175 | 0 | 4 |
| 2023 | 1 | — | 0 | 39 |
| 2024 | 3 | 207 | 0 | 12 |
| 2025 | 1 | — | 0 | 13 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The QuadraBloc TENS Model 101 is intended for use in relief of chronic intractable pain and adjunctive treatment of post-surgical or post-traumatic acute pain. This is a prescription device and should be used under continued medical supervision.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102278 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102278: Quadra Bloc Tens Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102278
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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