Analogic Corp.: FDA filings under this applicant name
FDA lists 39 510(k) clearances under the applicant name “Analogic Corp.” (first 1981, latest 2021), across 16 product codes in 4 review panels. Median 510(k) review time under this name: 86 days. Since 2017 the median was 222 days, against 134 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 47 |
| 2015 | 0 | — |
| 2016 | 1 | 33 |
| 2017 | 0 | — |
| 2018 | 2 | 126 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 271 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Analogic Corp. took a median 222 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 134 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | 7 | 7 |
| KPR | System, X-Ray, Stationary | 6 | 6 |
| HGM | System, Monitoring, Perinatal | 5 | 5 |
| DPS | Electrocardiograph | 3 | 3 |
| DSI | Detector And Alarm, Arrhythmia | 3 | 3 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 3 | 3 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | 2 |
| LLZ | System, Image Processing, Radiological | 2 | 2 |
| DSB | Plethysmograph, Impedance | 1 | 1 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 1 | 1 |
Plus 6 more product codes.
Review panels
- Radiology (19)
- Cardiovascular (13)
- Obstetrics and Gynecology (5)
- Anesthesiology (1)
Most recent Analogic Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K201231 | CTxx85 CT Scanner | JAK | 2021-02-02 | 271 |
| K182147 | CTXX85 | JAK | 2018-09-07 | 30 |
| K172058 | CT6485, CT12885 | JAK | 2018-02-13 | 222 |
| K161342 | Sonic Window | IYO | 2016-06-15 | 33 |
| K140126 | SONIC WINDOW | IYO | 2014-03-04 | 47 |
| K071430 | SYNERAD OMNI, MODELS AN6255 AND AN6265 | KPR | 2007-06-21 | 29 |
| K070829 | SYNEPIX 4600 DETECTOR | MQB | 2007-05-09 | 44 |
| K051903 | FETALGARD LITE-NIBP, MODEL FGL-NIBP | DXN | 2005-12-27 | 167 |
| K052447 | SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600 | JAK | 2005-09-21 | 14 |
| K050919 | LIFEGARD II FAMILY MULTI-FUNCTION PATIENT MONITOR, MODELS AN4320, AN4320P, AN4321P, AN4322P & AN3423P | DSI | 2005-06-14 | 63 |
29 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2005-10-14.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Analogic Corp.?
FDA lists 39 510(k) clearances under the applicant name “Analogic Corp.” (first 1981, latest 2021), across 16 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 Analogic Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Analogic Corp. is 86 days. Since 2017: 222 days, versus 134 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Analogic Corp.?
The most frequent FDA product codes under this applicant name are JAK (System, X-Ray, Tomography, Computed, 7); KPR (System, X-Ray, Stationary, 6); HGM (System, Monitoring, Perinatal, 5).
Next steps
- See all 39 Analogic Corp. clearances with predicates and recalls
- Run predicate analysis for product code JAK, Analogic Corp.'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.