Micro Direct, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Micro Direct, Inc.” (first 1994, latest 2004), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 182 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 |
|---|---|---|---|
| BZG | Spirometer, Diagnostic | 3 | 3 |
| NRH | System, Breath Measurement | 2 | 2 |
| BZH | Meter, Peak Flow, Spirometry | 1 | 1 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 | 1 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 1 | 1 |
| CCJ | Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase | 1 | 1 |
Review panels
- Anesthesiology (6)
- Clinical Chemistry (2)
- General Hospital (1)
Most recent Micro Direct, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K033688 | MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY | NRH | 2004-05-19 | 177 |
| K031102 | MICROLAB SPIROMETER | BZG | 2003-12-01 | 238 |
| K030586 | MICROPEAK | BZH | 2003-08-27 | 184 |
| K973314 | SPIROSAFE FILTER | CAH | 1997-11-21 | 79 |
| K965042 | MICRODL DIARYCARD SPIROMETER | BZG | 1997-06-17 | 182 |
| K963376 | MICRO H2 | NRH | 1997-01-24 | 150 |
| K963035 | MICRO SPIROMETER | BZG | 1996-11-01 | 88 |
| K950197 | MICROCO | CCJ | 1996-10-17 | 638 |
| K940375 | MICRO MPM | CAP | 1994-11-21 | 299 |
Recalls
openFDA lists no recalls under a recalling firm named Micro Direct, 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-Aire Surgical Instruments, Inc. (40 510(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 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 Direct, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Micro Direct, Inc.” (first 1994, latest 2004), across 6 product codes in 3 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 Direct, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Micro Direct, Inc. is 182 days.
Which FDA product codes appear under Micro Direct, Inc.?
The most frequent FDA product codes under this applicant name are BZG (Spirometer, Diagnostic, 3); NRH (System, Breath Measurement, 2); BZH (Meter, Peak Flow, Spirometry, 1).
Next steps
- See all 9 Micro Direct, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BZG, Micro Direct, 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.