510(k) · Cleared

Cleared

Frye Adjusting Instrument

K021238510(k) TraditionalCleared Oct 9, 2002174-day reviewClass U

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

Frye Health Systems · LXM Manipulator, Plunger-Like Joint

Cleared on Oct 9, 2002 as substantially equivalent to K003185 (Activator Methods International, Ltd., 2001) after a 174-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.

Decided: Oct 9, 2002
Review: 174 days
Class: Class U
Product code: LXM
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K003185 (2001). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK003185 FS Activator IiiActivator Methods International, Ltd. · 2001
This deviceK021238 Frye Adjusting InstrumentFrye Health Systems · 2002
Descendant · cites it directly · 0 of its ownK050428 Technology-Assisted Micro-Mobilization and Reflex Stimulator (Tamars)Advanced Spinal Technologies, Inc. · 2005

Most influential descendants

Showing 1 of 1 · See all

K050428Technology-Assisted Micro-Mobilization and Reflex Stimulator (Tamars)Advanced Spinal Technologies, Inc. · 2005 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K003185	FS Activator Iii	Activator Methods International, Ltd.	2001	—
0 (this device)	K021238	Frye Adjusting Instrument	Frye Health Systems	2002	—
+1	K050428	Technology-Assisted Micro-Mobilization and Reflex Stimulator (Tamars)	Advanced Spinal Technologies, Inc.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0

FIG. 1 — Lineage of K021238, 2001–2005Source: 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 LXM? 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 LXM device

#1 K234036 Sonik Monark 100score 7.5 · 3 generations · no Class I recall

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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
*	K003185	FS Activator Iii	Activator Methods International, Ltd.	2001	—

Also cleared against K003185: 4 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K050428	Technology-Assisted Micro-Mobilization and Reflex Stimulator (Tamars)	Advanced Spinal Technologies, Inc.	2005	0

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?

Its one ancestor has no recall.
Of its descendants, K050428 (Advanced Spinal Technologies, Inc., 2005) has gone furthest, with 0 descendants of its own.
4 other devices also cite its predicate K003185.

How does its category compare?

All LXM devices

LXM Manipulator, Plunger-Like Joint: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LXM

1in 2024

2007high 2 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LXM

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

Recalls per year · LXM

No recall names LXM since 2007.

Adverse event reports per year · LXM

1in 2020

2007high 3 (2016) · low 0 (2007)2025

MAUDE reports naming product code LXM, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	1	—	0
2008	2	—	0
2009	0	—	1
2010	0	—	0
2011	0	—	0
2012	1	—	0
2013	0	—	0
2014	1	—	0
2015	0	—	0
2016	1	—	3
2017	0	—	0
2018	1	—	1
2019	1	—	0
2020	0	—	1
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	1	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

The Frye Adjusting Instrument is indicated for chiropractic adjustment of the spine and extremities.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021238 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021238: Frye Adjusting Instrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021238

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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