Advanced Instrumentations, Inc.: FDA clearances and approvals
Advanced Instrumentations, Inc. has 16 FDA 510(k) clearances (first 2009, latest 2017), across 8 product codes in 4 review panels. Median 510(k) review time: 68 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 16 |
| 2013 | 2 | 110 |
| 2014 | 2 | 244 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 2 | 62 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Advanced Instrumentations, Inc.'s cleared 510(k)s took a median 62 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 125 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HGM | System, Monitoring, Perinatal | 4 | 4 |
| DPS | Electrocardiograph | 2 | 2 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | 2 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | 2 |
| KNG | Monitor, Ultrasonic, Fetal | 2 | 2 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 2 | 2 |
| BSZ | Gas-Machine, Anesthesia | 1 | 1 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 1 | 1 |
Review panels
- Obstetrics and Gynecology (6)
- Cardiovascular (5)
- Radiology (4)
- Anesthesiology (1)
Most recent Advanced Instrumentations, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K172931 | DUS-6000 Digital Ultrasonic Diagnostic Imaging System | IYO | 2017-12-01 | 67 |
| K172055 | DUS-7000 Digital Color Doppler Ultrasound System | IYN | 2017-08-31 | 56 |
| K141194 | FM-3000 FETAL MONITOR | HGM | 2014-11-19 | 195 |
| K132077 | PATIENT MONITOR | MHX | 2014-04-23 | 292 |
| K132059 | DIAGNOSTIC ULTRASOUND SYSTEM | IYN | 2013-10-25 | 114 |
| K123048 | PATIENT MONITOR MODELS PM-2000A, PM-2000A+, PM-2000A PRO | MHX | 2013-01-11 | 105 |
| K120075 | AM-6000 ANESTHESIA MACHINE | BSZ | 2012-01-26 | 16 |
| K112317 | FM-9000 PLUS FETAL AND MATERNAL MONITOR | HGM | 2011-12-21 | 132 |
| K112529 | TD-5000 & TD-6000 ULTRASONIC TABLETOP DOPPLER | KNG | 2011-10-27 | 57 |
| K112022 | DUS-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM | IYO | 2011-09-22 | 69 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Advanced Instrumentations, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Advanced Instrumentations, Inc. have?
Advanced Instrumentations, Inc. has 16 FDA 510(k) clearances (first 2009, latest 2017), across 8 product codes in 4 review panels.
How long does FDA take to clear Advanced Instrumentations, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Advanced Instrumentations, Inc.'s cleared 510(k)s is 68 days.
What devices does Advanced Instrumentations, Inc. make?
Its most frequent FDA product codes are HGM (System, Monitoring, Perinatal, 4); DPS (Electrocardiograph, 2); IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 2).
Has Advanced Instrumentations, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Advanced Instrumentations, Inc. Related entities may recall under other names.
Next steps
- See all 16 Advanced Instrumentations, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HGM, Advanced Instrumentations, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.