FDA applicant

Relievant Medsystems

Sunnyvale, CA10 decisions2007–20221 recall

FDA records 10 decisions for Relievant Medsystems (Sunnyvale, CA) from 2007 to 2022: 10 510(k) clearances. Most are in product codes GXI (Probe, Radiofrequency Lesion) and GEI (Electrosurgical, Cutting & Coagulation &…). Since 2016 its 510(k)s took a median of 142 days from receipt to decision, against 125 for FDA’s reviews in the same codes and years. Its devices cite 14 predicates, 9 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Relievant Medsystems, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Relievant Medsystems’s devices, and how often a recall has named them.

FDA decisions per year

2in 2022

2007high 2 (2017) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2026

2007high 1 (2026) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Relievant Medsystems by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Relievant Medsystems’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

GXIProbe, Radiofrequency Lesion6decisions
GEIElectrosurgical, Cutting & Coagulation & Accessories3decisions
GXDGenerator, Lesion, Radiofrequency1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 142 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 125 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 14 predicates; 9 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 12 times; 9 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

K153272INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument SetRelievant Medsystems · 20163cite it
K190504Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System…Relievant Medsystems · 20192cite it
K070443Intracept BI-Polar RF Probe, Model 04814Relievant Medsystems, Inc. · 20072cite it
K100641Intracept Flexible BI-Polar RF Probe and Easy Access Instrument Set, Model FG0018 (Probe), FG0036…Relievant Medsystems · 20101cites it
K213836Intracept Intraosseous Nerve Ablation SystemRelievant Medsystems, Inc. · 20221cites it
K170827INTRACEPT Intraosseous Nerve Ablation SystemRelievant Medsystems · 20171cites it

What has FDA decided for it lately?

K222281Intracept Intraosseous Nerve Ablation SystemRelievant Medsystems, Inc. · 20221 recall
K213836Intracept Intraosseous Nerve Ablation SystemRelievant Medsystems, Inc. · 2022
K190504Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System…Relievant Medsystems · 2019
K180369Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)Relievant Medsystems · 2018
K171143Relievant Medsystems RF GeneratorRelievant Medsystems · 2017
K170827INTRACEPT Intraosseous Nerve Ablation SystemRelievant Medsystems · 2017
K153272INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument SetRelievant Medsystems · 2016
K100641Intracept Flexible BI-Polar RF Probe and Easy Access Instrument Set, Model FG0018 (Probe), FG0036…Relievant Medsystems · 2010

All 6 as Relievant Medsystems →All 4 as Relievant Medsystems, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

K222281Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS-…Apr 22, 2026Class II