510(k) · Cleared

Cleared

Drug Relief v1

K221231510(k) SpecialCleared Jun 6, 202238-day reviewClass II21 CFR 882.5896

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Dyansys, Inc. · PZR Percutaneous Nerve Stimulator For Opioid Withdrawal

Cleared on Jun 6, 2022 as substantially equivalent to K211971 (Dyansys, Inc., 2021) after a 38-day review. Its family tree reaches back 3 generations to 2017.

Decided: Jun 6, 2022
Review: 38 days
Class: Class II
Product code: PZR
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to DEN170018 (2017). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backDEN170018 NSS-2 SystemInnovative Health Solutions (Ihs), Inc. · 2017
2 generations backK173861 Drug ReliefDyansys, Inc. · 2018
1 generation backK211971 Drug Relief v1Dyansys, Inc. · 2021
This deviceK221231 Drug Relief v1Dyansys, Inc. · 2022

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	DEN170018	NSS-2 System	Innovative Health Solutions (Ihs), Inc.	2017	—
−2	K173861	Drug Relief	Dyansys, Inc.	2018	—
−1	K211971	Drug Relief v1	Dyansys, Inc.	2021	—
0 (this device)	K221231	Drug Relief v1	Dyansys, Inc.	2022	—

FIG. 1 — Lineage of K221231, 2017–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 PZR? 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 PZR device

#1 K251246 Sparrow Ascentscore 10.5 · 3 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

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	Applicant	Decided	Recalls
*	K211971	Drug Relief v1 Summary page 4 …882.5896) Common Name: Percutaneous nerve stimulator Device Class: Class II Product Code: PZR III. PREDICATE DEVICE Model Name: Drug Relief v1 – (K211971) Manufacturer: DyAnsys Inc., The predicate device has not been subject to a design-related recall. IV. DEVICE DESCRIPTION The…	Dyansys, Inc.	2021	—

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 5 years and passes through 2 companies; a new generation was cleared every 7 months on median.
None of the 3 ancestors has a recall.

How does its category compare?

All PZR devices

PZR Percutaneous Nerve Stimulator For Opioid Withdrawal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.

FDA decisions per year · PZR

1in 2025

2007high 2 (2021) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PZR

Too few PZR 510(k)s in any year since 2007 to give a median.

Recalls per year · PZR

No recall names PZR since 2007.

Adverse event reports per year · PZR

No MAUDE report names PZR since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	1	—	0
2018	1	—	0
2019	0	—	0
2020	0	—	0
2021	2	—	0
2022	1	—	0
2023	1	—	0
2024	1	—	0
2025	1	—	0
2026	0	—	—

What is it indicated for?

The Drug Reliefv1 is a percutaneous nerve field stimulator (PNFS) system, that can be used as an aid to reduce the symptoms of opioid withdrawal, through application to branches of cranial nerves V, VII, IX and X, and the occipital nerves identified by transillumination.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K221231 · printed Nov 6, 2026

Cite this page

510(k) Report. “K221231: Drug Relief v1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221231

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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