510(k) · Cleared
ClearedGDC Patient Return Electtrode Model 45021
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Target Therapeutics · HCG Device, Neurovascular Embolization
Cleared on Dec 17, 1996 as substantially equivalent to K851522 (Sentry Medical Products, Inc., 1985) and 2 other predicates after a 117-day review. Its family tree reaches back 1 generation to 1985.
- Decided
- Dec 17, 1996
- Review
- 117 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K851522 (1985). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK851522 Diagnostic Ecg Disposable ElectrodeSentry Medical Products, Inc. · 1985
- This deviceK963307 GDC Patient Return Electtrode Model 45021Target Therapeutics · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K851522 | Diagnostic Ecg Disposable Electrode | Sentry Medical Products, Inc. | 1985 | — |
| 0 (this device) | K963307 | GDC Patient Return Electtrode Model 45021 | Target Therapeutics | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 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 HCG? 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 HCG device
- #1 K252700 Optima Coil System (Optima Packing Coil System)score 20.6 · 26 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 |
|---|---|---|---|
| * | K851522 | Diagnostic Ecg Disposable ElectrodeSummary page 1…de is indicated for use only with Target Therapeutics GDC System as the patient return electrode. PRED DEVICE: Product Design: Silver Sircuit™, Sentry Medical Products K851522 Indications for Use: Polyhesive® II, Valleylab, Inc K861036 Functional Performance: Hypodermic Needle, Target Therapeutics K95125… | 1985 |
| * | K861036 | E7509 Polyhesive II Patient Return ElectrodeSummary page 1…stem as the patient return electrode. PRED DEVICE: Product Design: Silver Sircuit™, Sentry Medical Products K851522 Indications for Use: Polyhesive® II, Valleylab, Inc K861036 Functional Performance: Hypodermic Needle, Target Therapeutics K951256 Patient Return Electrode Page 10 of 53 510(K) === Page… | 1986 |
| * | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Summary page 1…e (PRE) is a single use, disposable, non-sterile electrode. The PRE is intended to be used as an alternative patient return electrode for Target Therapeutics GDC system (K951256 & K960705). A hypodermic needle is currently used as the patient return electrode. The PRE is applied to the skin on the patient'… | 1995 |
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.
How does its category compare?
All HCG devicesHCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HCG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HCG
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HCG
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · HCG
537in 2025
MAUDE reports naming product code HCG, 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 | 8 | 50 | 1 | 326 |
| 2008 | 9 | 71 | 3 | 730 |
| 2009 | 7 | 48 | 0 | 821 |
| 2010 | 8 | 72 | 2 | 851 |
| 2011 | 9 | 78 | 1 | 894 |
| 2012 | 7 | 30 | 0 | 1,146 |
| 2013 | 7 | 67 | 2 | 1,103 |
| 2014 | 5 | 66 | 4 | 1,729 |
| 2015 | 5 | 60 | 0 | 1,598 |
| 2016 | 7 | 37 | 0 | 1,991 |
| 2017 | 5 | 97 | 0 | 2,494 |
| 2018 | 4 | 173 | 0 | 2,058 |
| 2019 | 1 | — | 0 | 1,763 |
| 2020 | 2 | — | 0 | 1,754 |
| 2021 | 5 | 103 | 0 | 2,268 |
| 2022 | 3 | 114 | 2 | 663 |
| 2023 | 2 | — | 0 | 568 |
| 2024 | 4 | 49 | 1 | 552 |
| 2025 | 3 | 107 | 1 (1) | 537 |
| 2026 | 4 | 30 | 1 | — |
What is it indicated for?
The Patient Return Electrode is indicated for use only with Target Therapeutics GDC System as the patient return electrode.
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/K963307 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963307: GDC Patient Return Electtrode Model 45021.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963307
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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