# LFL: Instrument, Ultrasonic Surgical

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 160
- 510(k) review time 2021–2025: median 143 days (middle half 62–251)
- Recalls: 81 (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)
- 2017: 2
- 2018: 3
- 2019: 4
- 2020: 4
- 2021: 6
- 2022: 8
- 2023: 4
- 2024: 3
- 2025: 3
- 2026: 3

## Most-cited predicates
- K981262: Cusa Excel Ultrasonic Surgical Aspirator System (1998), cited by 11
- K060245: Harmonic Scalpel Blades and Shears (2006), cited by 10
- K002906: Ultracision Harmonic Scalpel System, Models GEN01, GEN02, GEN03, HP052, HP053, HSA07 (2000), cited by 10
- K972114: Olympus Sonosurg System (1998), cited by 8
- K132612: Harmonic Ace+ Shears 23 CM Length with Advanced Hemostasis, Harmonic Ace + Laparoscopic Shears 36 CM Length with Advance (2013), cited by 8
- K990430: Ultracision Harmonic Scalpel Hand Piece (1999), cited by 7
- K980099: Ultracision  Laparosonic Coagulating Shears (LCS-5(LCSK5 and LCSB5)) (1998), cited by 6
- K000095: Olympus Sonosurg Trocar XT3900 System (2000), cited by 6
- K993054: Ultracision Harmonic Scalpel Coagulating Shears, Models LCS-C5, LCS-C1, CS-23C, CS-231, CS-14C, CS-141 (1999), cited by 6
- K050776: Auss-6 Ultrasonic Surgical Aspirator System (2005), cited by 6

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