510(k) · Cleared
ClearedHemostat/Stimulator Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rln Systems, Inc. · ETN Stimulator, Nerve
Cleared on Dec 8, 1989 after a 79-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Dec 8, 1989
- Review
- 79 days
- Class
- Class II
- Product code
- ETN
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK895676 Hemostat/Stimulator ProbeRln Systems, Inc. · 1989
- Descendant · cites it directly · 3 of its ownK110712 Drytouch Suction Stimulator ProbeNeurovision Medical Products, Inc. · 2011
- Descendant · 2 generations on · 1 of its ownK133348 Stim ProbeSpes Medica Srl · 2014 · Recalled
- Descendant · 2 generations on · 0 of its ownK212164 Mapping Suction ProbeInomed Medizintechnik GmbH · 2022
- Descendant · 3 generations on · 0 of its ownK152769 Fremap ElectrodeAd-Tech Medical Instrument Corporation · 2016
- Descendant · cites it directly · 0 of its ownK121931 Nondisposable Stimulating InstrumentsNeurovision Medical Products, Inc. · 2012
Most influential descendants
Showing 5 of 5 · See all- K110712Drytouch Suction Stimulator ProbeNeurovision Medical Products, Inc. · 2011 · cites it directly3descendants
- K133348Stim ProbeSpes Medica Srl · 2014 · 2 generations on1descendant
- K212164Mapping Suction ProbeInomed Medizintechnik GmbH · 2022 · 2 generations on0descendants
- K152769Fremap ElectrodeAd-Tech Medical Instrument Corporation · 2016 · 3 generations on0descendants
- K121931Nondisposable Stimulating InstrumentsNeurovision Medical Products, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K895676 | Hemostat/Stimulator Probe | Rln Systems, Inc. | 1989 | — |
| +1 | K110712 | Drytouch Suction Stimulator Probe | Neurovision Medical Products, Inc. | 2011 | — |
| +2 | K133348 | Stim Probe | Spes Medica Srl | 2014 | 1 |
| +2 | K212164 | Mapping Suction Probe | Inomed Medizintechnik GmbH | 2022 | — |
| +3 | K152769 | Fremap Electrode | Ad-Tech Medical Instrument Corporation | 2016 | — |
| +1 | K121931 | Nondisposable Stimulating Instruments | Neurovision Medical Products, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ETN? 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 ETN device
- #1 K251672 NIM Essence™ EMG Endotracheal Tube…score 12.3 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
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?
- Of its descendants, K110712 (Neurovision Medical Products, Inc., 2011) has gone furthest, with 3 descendants of its own.
How does its category compare?
All ETN devicesETN Stimulator, Nerve: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ETN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ETN
98in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ETN
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ETN
1,145in 2025
MAUDE reports naming product code ETN, 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 | 5 |
| 2008 | 2 | — | 1 | 5 |
| 2009 | 5 | 115 | 0 | 22 |
| 2010 | 3 | 168 | 1 | 26 |
| 2011 | 9 | 115 | 0 | 55 |
| 2012 | 7 | 179 | 0 | 187 |
| 2013 | 1 | — | 0 | 270 |
| 2014 | 2 | — | 0 | 137 |
| 2015 | 1 | — | 0 | 202 |
| 2016 | 2 | — | 1 | 145 |
| 2017 | 0 | — | 0 | 117 |
| 2018 | 0 | — | 0 | 250 |
| 2019 | 0 | — | 2 | 314 |
| 2020 | 1 | — | 1 | 238 |
| 2021 | 1 | — | 1 | 197 |
| 2022 | 2 | — | 0 | 247 |
| 2023 | 5 | 98 | 1 | 390 |
| 2024 | 2 | — | 0 | 748 |
| 2025 | 1 | — | 0 | 1,145 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K895676 · printed Nov 6, 2026
Cite this page
510(k) Report. “K895676: Hemostat/Stimulator Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K895676
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026