Micro-Aire Surgical Instruments, Inc.: FDA filings under this applicant name
FDA lists 40 510(k) clearances under the applicant name “Micro-Aire Surgical Instruments, Inc.” (first 1981, latest 1990), across 21 product codes in 6 review panels. Median 510(k) review time under this name: 32 days. 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HSZ | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | 8 | 8 |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | 4 | 4 |
| GFF | Bur, Surgical, General & Plastic Surgery | 4 | 4 |
| EFB | Handpiece, Air-Powered, Dental | 2 | 2 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | 2 | 2 |
| FQH | Lavage, Jet | 2 | 2 |
| GEY | Motor, Surgical Instrument, Ac-Powered | 2 | 2 |
| HRX | Arthroscope | 2 | 2 |
| DWH | Blade, Saw, Surgical, Cardiovascular | 1 | 1 |
| DZP | Instrument, Diamond, Dental | 1 | 1 |
Plus 11 more product codes.
Review panels
- General and Plastic Surgery (16)
- Orthopedic (14)
- Dental (3)
- Ear, Nose and Throat (2)
- General Hospital (2)
- Neurology (1)
Most recent Micro-Aire Surgical Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K904949 | A.O. SYNTHES,TAP(REPLACEMENT)VARIOUS MODEL NUMBERS | HSZ | 1990-11-26 | 24 |
| K903713 | OSTEOTOME MODEL NUMBERS 2500-228 & 2500-229 | HSZ | 1990-09-14 | 31 |
| K903650 | OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-305 | HWE | 1990-09-14 | 32 |
| K902676 | MICROGUARD, ORTHOPEDIC PIN PROTECTORS | LYT | 1990-09-14 | 87 |
| K903664 | MICRO-AIRE WIRE PASS AND CRANIOTOME DRILL | HBE | 1990-09-13 | 30 |
| K901967 | DENDIA WERK BURS AND CUTTING DISCS | DZP | 1990-07-13 | 73 |
| K902168 | ARTHROSCOPIC SURGERY BLADES (SEVERAL MODELS) | HRX | 1990-06-20 | 36 |
| K901735 | ARTHROSCOPIC SURGERY BLADES DY-3440, 3443, 3444 | HRX | 1990-06-20 | 64 |
| K900033 | MICRO-AIRE POWERED MICRO-SURGERY INSTRUMENTS | GEY | 1990-02-13 | 42 |
| K900210 | BONE HARVESTER SYSTEM & OSTEOTOME SYSTEM 2500 | HSZ | 1990-02-02 | 16 |
30 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Micro-Aire Surgical Instruments, Inc..
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.
- Micro Media Laboratories (52 510(k)s)
- Micro Therapeutics, Inc. (51 510(k)s)
- Micro-Tech (Nanjing) Co., Ltd. (41 510(k)s)
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (32 510(k)s)
- Micro Surgical Instruments Corp. (15 510(k)s)
- Micro Motors, Inc. (14 510(k)s)
- Micro Detect, Inc. (11 510(k)s)
- Micro-Mega Societe Anonyme (11 510(k)s)
- Micro-Bio-Logics (9 510(k)s)
- Micro Direct, Inc. (9 510(k)s)
- Micro Current Technology, Inc. (8 510(k)s)
- Micro-Medical Devices, Inc. (8 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Micro-Aire Surgical Instruments, Inc.?
FDA lists 40 510(k) clearances under the applicant name “Micro-Aire Surgical Instruments, Inc.” (first 1981, latest 1990), across 21 product codes in 6 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 Micro-Aire Surgical Instruments, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Micro-Aire Surgical Instruments, Inc. is 32 days.
Which FDA product codes appear under Micro-Aire Surgical Instruments, Inc.?
The most frequent FDA product codes under this applicant name are HSZ (Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment, 8); GFA (Blade, Saw, General & Plastic Surgery, Surgical, 4); GFF (Bur, Surgical, General & Plastic Surgery, 4).
Next steps
- See all 40 Micro-Aire Surgical Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HSZ, Micro-Aire Surgical Instruments, Inc.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.