Microaire Surgical Instruments, LLC: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Microaire Surgical Instruments, LLC” (first 1996, latest 2025), across 7 product codes in 4 review panels. Median 510(k) review time under this name: 118 days. Since 2017 the median was 142 days, against 132 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 298 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 58 |
| 2016 | 0 | — |
| 2017 | 1 | 165 |
| 2018 | 1 | 120 |
| 2019 | 0 | — |
| 2020 | 1 | 231 |
| 2021 | 1 | 57 |
| 2022 | 2 | 300 |
| 2023 | 1 | 85 |
| 2024 | 1 | 104 |
| 2025 | 2 | 164 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Microaire Surgical Instruments, LLC took a median 142 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 132 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QPB | System, Suction, Lipoplasty For Removal | 8 | 8 |
| HRX | Arthroscope | 3 | 3 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 | 1 |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | 1 | 1 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | 1 | 1 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 1 | 1 |
| MUU | System, Suction, Lipoplasty | 1 | 1 |
Review panels
- General and Plastic Surgery (10)
- Orthopedic (4)
- General Hospital (1)
- Neurology (1)
Most recent Microaire Surgical Instruments, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243589 | PAL Sterilization Case | KCT | 2025-06-20 | 212 |
| K244026 | PAL 7020 Console | QPB | 2025-04-25 | 116 |
| K242804 | PAL Aspiration System | QPB | 2024-12-30 | 104 |
| K223406 | SmartRelease Endoscopic Soft Tissue Release System | HRX | 2023-02-02 | 85 |
| K220318 | PAL Infiltration System | QPB | 2022-10-14 | 253 |
| K212024 | PAL System | QPB | 2022-06-10 | 346 |
| K211297 | SMARTRELEASE Endoscopic Soft Tissue Release System | HRX | 2021-06-24 | 57 |
| K192694 | PAL Single-Use Cannulas | QPB | 2020-05-14 | 231 |
| K181819 | SMARTRELEASE Endoscopic Soft Tissue Release System | HRX | 2018-11-06 | 120 |
| K171286 | PAL Multi-Use Cannulas and PAL Manual Wand | QPB | 2017-10-13 | 165 |
6 earlier clearances. See the full list in Caduvo.
Recalls
16 product recalls in 13 recall events; 1 initiated in the last five years. Most recent: 2025-05-07.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Microaire (3 510(k)s)
- Microaire Advanced Surgical Products (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Microaire Surgical Instruments, LLC?
FDA lists 16 510(k) clearances under the applicant name “Microaire Surgical Instruments, LLC” (first 1996, latest 2025), across 7 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Microaire Surgical Instruments, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Microaire Surgical Instruments, LLC is 118 days. Since 2017: 142 days, versus 132 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Microaire Surgical Instruments, LLC?
The most frequent FDA product codes under this applicant name are QPB (System, Suction, Lipoplasty For Removal, 8); HRX (Arthroscope, 3); BTA (Pump, Portable, Aspiration (Manual Or Powered), 1).
Next steps
- See all 16 Microaire Surgical Instruments, LLC clearances with predicates and recalls
- Run predicate analysis for product code QPB, Microaire Surgical Instruments, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.