Advanced Instruments, Inc.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Advanced Instruments, Inc.” (first 1979, latest 2016), across 10 product codes in 6 review panels. Median 510(k) review time under this name: 75 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 | 1 | 85 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 245 |
| 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 |
|---|---|---|---|
| JJM | Osmometer For Clinical Use | 7 | 7 |
| CIG | Diazo Colorimetry, Bilirubin | 1 | 1 |
| DQA | Oximeter | 1 | 1 |
| GKL | Counter, Cell, Automated (Particle Counter) | 1 | 1 |
| GWQ | Full-Montage Standard Electroencephalograph | 1 | 1 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 | 1 |
| JOW | Sleeve, Limb, Compressible | 1 | 1 |
| LMC | Camera, Multi Format, Radiological | 1 | 1 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 1 | 1 |
Plus 1 more product codes.
Review panels
- Clinical Chemistry (9)
- Cardiovascular (2)
- Anesthesiology (1)
- Hematology (1)
- Neurology (1)
- Radiology (1)
Most recent Advanced Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K152776 | Glocyte Automated Cell Counter System | GKL | 2016-05-27 | 245 |
| K120631 | PATIENT MONITOR | MHX | 2012-05-25 | 85 |
| K112465 | VITAL SIGNS MONITOR | DQA | 2011-09-14 | 19 |
| K965036 | THE ADVANCED OSMOMETER (3900) | JJM | 1997-02-20 | 65 |
| K962056 | ADVANCED MICRO-OSMOMETER MODEL 3300 | JJM | 1996-07-11 | 44 |
| K930526 | INTERMITTENT COMPRESSION SYSTEM MODEL 5000 | JOW | 1993-11-18 | 289 |
| K925970 | MODEL 3D3 OSMOMETER | JJM | 1993-07-09 | 226 |
| K911092 | OSMOMETER MODEL 2400 | JJM | 1991-05-22 | 72 |
| K873642 | OSMOMETER MODEL 110 | JJM | 1987-10-20 | 41 |
| K863516 | ELECTRONIC METAL LOCATOR MODEL MD-1 | — | 1986-09-30 | 21 |
6 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 3 recall events; 1 initiated in the last five years. Most recent: 2024-03-11.
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.
- Advanced Cardiovascular Systems, Inc. (103 510(k)s)
- Advanced Surgical Products, Inc. (64 510(k)s)
- Advanced Technology Laboratories, Inc. (61 510(k)s)
- Advanced Sterilization Products (59 510(k)s)
- Advanced Neuromodulation Systems (25 510(k)s)
- Advanced Orthopaedic Solutions, Inc. (24 510(k)s)
- Advanced Biosearch Assn. (22 510(k)s)
- Advanced Biomedical Methods, Inc. (21 510(k)s)
- Advanced Surgical, Inc. (21 510(k)s)
- Advanced Clinical Diagnostics (19 510(k)s)
- Advanced Instrumentations, Inc. (16 510(k)s)
- Advanced Spine Fixation Systems, Inc. (16 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Advanced Instruments, Inc.?
FDA lists 16 510(k) clearances under the applicant name “Advanced Instruments, Inc.” (first 1979, latest 2016), across 10 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 Advanced Instruments, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Advanced Instruments, Inc. is 75 days.
Which FDA product codes appear under Advanced Instruments, Inc.?
The most frequent FDA product codes under this applicant name are JJM (Osmometer For Clinical Use, 7); CIG (Diazo Colorimetry, Bilirubin, 1); DQA (Oximeter, 1).
Next steps
- See all 16 Advanced Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JJM, Advanced 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, 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.