510(k) Report

510(k) · Cleared

Cleared

Spine Tuner Posture Trainer

K951244510(k) TraditionalCleared Jun 26, 1995105-day reviewClass U

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

Dan Kline · LZW Monitor, Spine Curvature

Cleared on Jun 26, 1995 after a 105-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.

Decided
Jun 26, 1995
Review
105 days
Class
Class U
Product code
LZW
Recalls
None
Predicates
0

2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared2009: 1 descendant cleared1995200020052010201520202025
  1. This deviceK951244 Spine Tuner Posture TrainerDan Kline · 1995
  2. Descendant · cites it directly · 1 of its ownK081540 Zegra Posture TrainerPeter Fischer · 2009
  3. Descendant · cites it directly · 0 of its ownK093553 PosturetekPerseus Althetics,Llc · 2010

Most influential descendants

Showing 2 of 2 · See all
  • K081540Zegra Posture TrainerPeter Fischer · 2009 · cites it directly1descendant
  • K093553PosturetekPerseus Althetics,Llc · 2010 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K951244Spine Tuner Posture TrainerDan Kline1995—
+1K081540Zegra Posture TrainerPeter Fischer2009—
+1K093553PosturetekPerseus Althetics,Llc2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201010
FIG. 1 — Lineage of K951244, 1995–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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 LZW? 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
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K081540Zegra Posture TrainerPeter Fischer20091
K093553PosturetekPerseus Althetics,Llc20100

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, K081540 (Peter Fischer, 2009) has gone furthest, with 1 descendant of its own.

How does its category compare?

All LZW devices

LZW Monitor, Spine Curvature: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LZW

1in 2010

2009: 12010: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZW

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

Recalls per year · LZW

No recall names LZW since 2007.

Adverse event reports per year · LZW

1in 2025

2021: 12025: 1
2007high 1 (2021) · low 0 (2007)2025

MAUDE reports naming product code LZW, 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
20101—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—01
20220—00
20230—00
20240—00
20250—01
20260—0—
Cite this page

510(k) Report. “K951244: Spine Tuner Posture Trainer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K951244

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026