510(k) Report

510(k) · Cleared

Cleared

Coda MPX30 Motion Analysis System

K982425510(k) TraditionalCleared Oct 7, 199886-day reviewClass II21 CFR 890.5360

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

Pinsco Inc. Dba B & L Engineering · LXJ Interactive Rehabilitation Exercise Devices

Cleared on Oct 7, 1998 as substantially equivalent to K890076 (Motion Analysis Corp., 1989) after an 86-day review. Its family tree reaches back 1 generation to 1989. 13 later devices descend from it.

Decided
Oct 7, 1998
Review
86 days
Class
Class II
Product code
LXJ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K890076 (1989). 13 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2003: 1 descendant cleared2014: 2 descendants cleared2015: 3 descendants cleared2019: 1 descendant cleared2009: 1 descendant cleared2017: 1 descendant cleared2016: 1 descendant cleared2018: 2 descendants clearedK890076 · Orthotrak · Motion Analysis Corp. · 19891990200020102020
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 5 descendants3 generations forward: 5 descendants4 generations forward: 1 descendant K890076 · Orthotrak · Motion Analysis Corp. · 19890
  1. Root · 1 generation backK890076 OrthotrakMotion Analysis Corp. · 1989
  2. This deviceK982425 Coda MPX30 Motion Analysis SystemPinsco Inc. Dba B & L Engineering · 1998
  3. Descendant · cites it directly · 10 of its ownK033514 Coda CX1 Motion Analysis SystemCharnwood Dynamics, Ltd. · 2004
  4. Descendant · cites it directly · 10 of its ownK030714 Peak MotusPeak Performance Technologies, Inc. · 2003
  5. Descendant · 2 generations on · 6 of its ownK130847 Jintronix Rehabilitation System (JRS)Jintronix, Inc. · 2014
  6. Descendant · 3 generations on · 1 of its ownK151446 Recovr Rehabilitation SystemRecovr,Inc · 2015
  7. Descendant · 2 generations on · 1 of its ownK131660 Smart (Smart-D, Smart-DX)Bts S.P.A. · 2014

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2003: 12004: 12009: 12014: 22015: 32016: 12017: 12018: 22019: 1
2003high 3 (2015) · low 0 (2005)2026

Most influential descendants

Showing 5 of 13 · See all
  • K033514Coda CX1 Motion Analysis SystemCharnwood Dynamics, Ltd. · 2004 · cites it directly10descendants
  • K030714Peak MotusPeak Performance Technologies, Inc. · 2003 · cites it directly10descendants
  • K130847Jintronix Rehabilitation System (JRS)Jintronix, Inc. · 2014 · 2 generations on6descendants
  • K151446Recovr Rehabilitation SystemRecovr,Inc · 2015 · 3 generations on1descendant
  • K131660Smart (Smart-D, Smart-DX)Bts S.P.A. · 2014 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K890076OrthotrakMotion Analysis Corp.1989—
0 (this device)K982425Coda MPX30 Motion Analysis SystemPinsco Inc. Dba B & L Engineering1998—
+1K033514Coda CX1 Motion Analysis SystemCharnwood Dynamics, Ltd.2004—
+1K030714Peak MotusPeak Performance Technologies, Inc.2003—
+2K130847Jintronix Rehabilitation System (JRS)Jintronix, Inc.2014—
+3K151446Recovr Rehabilitation SystemRecovr,Inc2015—
+2K131660Smart (Smart-D, Smart-DX)Bts S.P.A.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200410
200910
201420
201530
201610
201710
201820
201910
FIG. 1 — Lineage of K982425, 1989–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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 LXJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

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.

TypeNumberDeviceApplicantDecidedRecalls
*K890076Orthotrak
Summary page 1
…em 6. Common Name: Motion Analysis System 7. Classification Name: System / Optical Position / Movement Recording 8. Identification of Predicate Device(s): OrthoTrak IT (K 890076) 9. Device Description: CODA mpx30 is an optical/electronic system which measures and analyses the 3D position and movement of m…
Motion Analysis Corp.1989—

What descends from it? (13)

See all 13

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K033514Coda CX1 Motion Analysis SystemCharnwood Dynamics, Ltd.200410
K030714Peak MotusPeak Performance Technologies, Inc.200310

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, K033514 (Charnwood Dynamics, Ltd., 2004) has gone furthest, with 10 descendants of its own.

How does its category compare?

All LXJ devices

LXJ Interactive Rehabilitation Exercise Devices: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LXJ

3in 2019

2009: 12014: 22015: 32016: 12017: 22018: 32019: 3
2007high 3 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LXJ

224in 2019

2015: 182 days median2018: 231 days median2019: 224 days median
2007high 231 (2018) · low 182 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LXJ

No recall names LXJ since 2007.

Adverse event reports per year · LXJ

1in 2018

2018: 1
2007high 1 (2018) · low 0 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20091—00
20100—00
20110—00
20120—00
20130—00
20142—00
2015318200
20161—00
20172—00
2018323101
2019322400
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The Coda mpx30 system has general application to measurement and recording of 3D position and movement, including human movement. It is appropriate for use in assessment of the 3D motion of the limbs and body of patients who have some impairment of movement functions of either a neurological or orthopaedic cause.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K982425: Coda MPX30 Motion Analysis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K982425

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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