510(k) Report

510(k) · Cleared

Cleared

Lateral Flexion Machine

K940455510(k) TraditionalCleared Jan 12, 1995345-day reviewClass I21 CFR 890.5380

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

Rehab, Inc. · BXB Exerciser, Powered

Cleared on Jan 12, 1995 after a 345-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jan 12, 1995
Review
345 days
Class
Class I
Product code
BXB
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K940455Source: FDA 510(k) database · 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 BXB? 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 has not posted a summary or statement for it, so its predicates are not known.

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.

How does its category compare?

All BXB devices

BXB Exerciser, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BXB

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BXB

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

Recalls per year · BXB

1in 2012

2009: 12011: 12012: 1
2007high 1 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · BXB

4in 2025

2007: 12008: 102009: 42010: 72011: 52012: 22013: 82014: 52015: 62016: 62017: 42018: 22019: 22021: 22023: 152024: 22025: 4
2007high 15 (2023) · low 0 (2020)2025

MAUDE reports naming product code BXB, 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—01
20081—010
20090—14
20100—07
20110—15
20120—12
20130—08
20140—05
20150—06
20160—06
20170—04
20180—02
20190—02
20200—00
20210—02
20220—00
20230—015
20240—02
20250—04
20260—0—

Recent decisions in BXB

The BXB category page

  • K072887G-Trainer MedicalAlter-G, Inc. · 20081 recall
  • K003272Flo-BootDiscovery Group, LLC · 2001
  • K952975Ankle Calf Exerciser PhlebopumpPrevent Products, Inc. · 1996
  • K953456E-Z FlexFluid Motion Biotechnologies, Inc. · 1996
  • K955105Bte CPM-10Baltimore Therapeutic Equipment Co. · 1995

https://510kreport.com/device/K940455 · printed Nov 4, 2026

Cite this page

510(k) Report. “K940455: Lateral Flexion Machine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K940455

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