510(k) · Cleared
ClearedMedtronic Model 3273/3274 RF Receiver and Model 3629/3630 Screener
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)
Cleared on Aug 22, 1997 as substantially equivalent to K934065 (Medtronic Vascular, 1995) and 2 other predicates after an 81-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Aug 22, 1997
- Review
- 81 days
- Class
- Class II
- Product code
- GZB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K904409 (1991). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK904409 Medtronic (R) Model 3470 X-Trel (TM) ReceiverMedtronic Vascular · 1991
- This deviceK972043 Medtronic Model 3273/3274 RF Receiver and Model 3629/3630 ScreenerMedtronic Vascular · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K904409 | Medtronic (R) Model 3470 X-Trel (TM) Receiver | Medtronic Vascular | 1991 | — |
| 0 (this device) | K972043 | Medtronic Model 3273/3274 RF Receiver and Model 3629/3630 Screener | Medtronic Vascular | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 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 GZB? 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 GZB device
- #1 K221376 Nalu Neurostimulation Systemscore 8.9 · 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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K934065 | Medtronic Mattrix 3271/3272 Neurostimulation SystemSummary page 1…and patient to customize or balance the stimulation to optimally control pain. The Model 3272/3274 Receiver is substantially equivalent to the Model 3271/3272 Receiver (K934065), Model 3470 Receiver (K904409A), the Model 3462B RF Receiver (K823130), and other commercially available RF receivers. The Mode… | 1995 |
| * | K904409 | Medtronic (R) Model 3470 X-Trel (TM) ReceiverSummary page 1…ance the stimulation to optimally control pain. The Model 3272/3274 Receiver is substantially equivalent to the Model 3271/3272 Receiver (K934065), Model 3470 Receiver (K904409A), the Model 3462B RF Receiver (K823130), and other commercially available RF receivers. The Model 3629/3630 Screener is connect… | 1991 |
| Kept off the family tree | K823130 | Model 3462B RF Receiver Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…l pain. The Model 3272/3274 Receiver is substantially equivalent to the Model 3271/3272 Receiver (K934065), Model 3470 Receiver (K904409A), the Model 3462B RF Receiver (K823130), and other commercially available RF receivers. The Model 3629/3630 Screener is connected to the (temporary) percutaneous exten… | |
| * | K903690 | Medtronic (R) Model 3625 ScreenerSummary page 2…ause they should be identical to those of commercially available predicate devices. The Model 3629/3630 Screener is substantially equivalent to the Model 3625 Screener (K903690B), Model 3627 Screener (K934065), and other commercially available screeners. Therefore, these devices are substantially equival… | 1991 |
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?
- None of the 3 ancestors has a recall.
- 4 other devices also cite its predicate K934065.
How does its category compare?
All GZB devicesGZB Stimulator, Spinal-Cord, Implanted (Pain Relief): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GZB
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GZB
149in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GZB
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GZB
313in 2025
MAUDE reports naming product code GZB, 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 | 2 | — | 0 | 201 |
| 2008 | 1 | — | 1 | 68 |
| 2009 | 3 | 62 | 0 | 59 |
| 2010 | 1 | — | 1 | 157 |
| 2011 | 4 | 67 | 0 | 471 |
| 2012 | 2 | — | 0 | 1,090 |
| 2013 | 2 | — | 0 | 4,428 |
| 2014 | 2 | — | 0 | 10,849 |
| 2015 | 2 | — | 0 | 7,507 |
| 2016 | 2 | — | 0 | 4,556 |
| 2017 | 2 | — | 0 | 5,511 |
| 2018 | 1 | — | 0 | 5,244 |
| 2019 | 4 | 149 | 0 | 643 |
| 2020 | 2 | — | 0 | 466 |
| 2021 | 1 | — | 0 | 332 |
| 2022 | 1 | — | 0 | 209 |
| 2023 | 0 | — | 0 | 236 |
| 2024 | 1 | — | 0 | 318 |
| 2025 | 0 | — | 0 | 313 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
Model 3273/3274 Receiver and Model 3626/3630 Screener indicated for use for epidural spinal cord stimulation (SCS) and peripheral nerve stimulation (PNS), as an aid in the treatment of chronic intractable pain of the trunk and/or limbs.
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/K972043 · printed Nov 5, 2026
Cite this page
510(k) Report. “K972043: Medtronic Model 3273/3274 RF Receiver and Model 3629/3630 Screener.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972043
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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