# LXM: Manipulator, Plunger-Like Joint

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 32
- 510(k) review time 2021–2025: median 56 days (middle half 56–56)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2005: 1
- 2006: 1
- 2007: 1
- 2008: 2
- 2012: 1
- 2014: 1
- 2016: 1
- 2018: 1
- 2019: 1
- 2024: 1

## Most-cited predicates
- K003185: FS Activator Iii (2001), cited by 5
- K010851: Harrison Hand Held Adjusting Instrument (2001), cited by 4
- K023462: Impulse-Adjusting Instrument, CBP Adjusting Instrument, Neuromechanical Adjusting Instrument, Models 2003 (2003), cited by 3
- K930431: Arthrostim Manipulator (1994), cited by 3
- K973914: Sense Technology Inc. Fras, Sense Technology Inc. Pulstar (1998), cited by 2
- K130666: Khan Kinetic Treatment (KKT-M2) (2014), cited by 2
- K080261: Impulse IQ Adjusting Instrument (2008), cited by 2
- K962239: Smart Adjuster (SA201) (1997), cited by 2
- K060043: Khan Kinetic Treatment Device (KKT-M1) (2006), cited by 1
- K950646: Integrator (1996), cited by 1

Source page: https://510kreport.com/product-code/LXM
Data by year (CSV): https://510kreport.com/product-code/LXM.csv