# Microaire Surgical Instruments, LLC

- Location (FDA's records): Charlottesville, VA
- FDA decisions: 16 (1996–2025): 16 510(k) clearances
- Names in FDA's records: Microaire Surgical Instruments, LLC (9); Microaire Surgical Instruments, Inc. (4); Microaire Surgical Instruments (3)
- Product codes: QPB (8), HRX (3), KCT (1), HWE (1), HBE (1), BTA (1), MUU (1)
- 510(k) review time since 2016: median 112 days, against 153 for FDA's reviews in the same codes and years (2 of 6 faster)
- Predicates its devices cite: 21 (4 its own); citations of its devices by later devices: 21 (4 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- A.M. Surgical, Inc.: 2 (https://510kreport.com/company/am-surgical)
- Norman M. Black Iii: 2 (https://510kreport.com/company/norman-m-black-iii)
- Sound Surgical Technologies, LLC: 2 (https://510kreport.com/company/sound-surgical-technologies)
- Black & Black Surgical, Inc.: 2 (https://510kreport.com/company/black-black-surgical)
- Covidien: 1 (https://510kreport.com/company/covidien)
- Henke Sass Wolf of America, Inc.: 1 (https://510kreport.com/company/henke-sass-wolf-of-america)
- Paragon Medical: 1 (https://510kreport.com/company/paragon-medical)
- Stryker Instruments: 1 (https://510kreport.com/company/stryker-instruments)

## Firms that cite its devices most
- Xomed, Inc.: 2 (https://510kreport.com/company/xomed)
- Hand Biomechanics Lab, Inc.: 2 (https://510kreport.com/company/hand-biomechanics-lab)
- Alma Lasers, Inc.: 2 (https://510kreport.com/company/alma-lasers)
- Apyx Medical Corporation: 2 (https://510kreport.com/company/apyx-medical)
- Rafael Medical Devices, LLC: 1 (https://510kreport.com/company/rafael-medical-devices)
- Conmed Linvatec: 1 (https://510kreport.com/company/conmed-linvatec)
- Black & Black Surgical, Inc.: 1 (https://510kreport.com/company/black-black-surgical)
- Aesculap, Inc.: 1 (https://510kreport.com/company/aesculap)

## Its most-cited devices
- K181819: SMARTRELEASE Endoscopic Soft Tissue Release System (2018), cited by 4
- K981922: Light Duty Pneumatic Instrument Model Number Pad-100, Heavy Duty Pneumatic Instrument Model Pad-200, Light Duty Electri (1998), cited by 4
- K014060: Microaire 1000E System (2002), cited by 3
- K212024: PAL System (2022), cited by 3
- K171286: PAL Multi-Use Cannulas and PAL Manual Wand (2017), cited by 2
- K223406: SmartRelease Endoscopic Soft Tissue Release System (2023), cited by 2

## Recent decisions
- K243589: PAL Sterilization Case (Jun 20, 2025)
- K244026: PAL 7020 Console (Apr 25, 2025)
- K242804: PAL Aspiration System (Dec 30, 2024)
- K223406: SmartRelease Endoscopic Soft Tissue Release System (Feb 2, 2023)
- K220318: PAL Infiltration System (Oct 14, 2022)
- K212024: PAL System (Jun 10, 2022)
- K211297: SMARTRELEASE Endoscopic Soft Tissue Release System (Jun 24, 2021)
- K192694: PAL Single-Use Cannulas (May 14, 2020)

Source page: https://510kreport.com/company/microaire-surgical-instruments