Ackrad Laboratories: FDA clearances and approvals
Ackrad Laboratories has 42 FDA 510(k) clearances (first 1979, latest 2002), across 25 product codes in 8 review panels. Median 510(k) review time: 48 days.
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 |
|---|---|---|---|
| LKF | Cannula, Manipulator/Injector, Uterine | 6 | 6 |
| BSY | Catheters, Suction, Tracheobronchial | 4 | 4 |
| BZD | Ventilator, Non-Continuous (Respirator) | 4 | 4 |
| BSR | Stylet, Tracheal Tube | 2 | 2 |
| CBH | Device, Fixation, Tracheal Tube | 2 | 2 |
| JAY | Support, Breathing Tube | 2 | 2 |
| KNA | Instrument, Manual, Specialized Obstetric-Gynecologic | 2 | 2 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 2 | 2 |
| KOD | Catheter, Urological | 2 | 2 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 1 | 1 |
Plus 15 more product codes.
Review panels
- Anesthesiology (18)
- Obstetrics and Gynecology (10)
- Gastroenterology and Urology (5)
- General Hospital (4)
- Cardiovascular (1)
- Microbiology (1)
- Physical Medicine (1)
- General and Plastic Surgery (1)
Most recent Ackrad Laboratories 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K021272 | SIB CATHETER, MODEL 61-7005 | LKF | 2002-05-21 | 29 |
| K020954 | H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAY | LKF | 2002-04-24 | 30 |
| K020951 | H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007 | LKF | 2002-04-16 | 22 |
| K970492 | INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER | LKF | 1997-04-09 | 58 |
| K961752 | H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) | LKF | 1996-08-08 | 94 |
| K952542 | ACKRAD ESOPHAGEAL BALLOON CATHETER SET | BZC | 1996-04-23 | 336 |
| K940176 | ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION | MFD | 1996-04-23 | 833 |
| K953034 | H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) | LKF | 1995-08-29 | 71 |
| K915813 | ACKRAD ERCP CONTRAST DELIVERY SET | FGE | 1992-03-11 | 72 |
| K904499 | NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM) | KFG | 1991-07-01 | 273 |
32 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ackrad Laboratories.
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 Ackrad Laboratories have?
Ackrad Laboratories has 42 FDA 510(k) clearances (first 1979, latest 2002), across 25 product codes in 8 review panels.
How long does FDA take to clear Ackrad Laboratories's 510(k)s?
The median time from FDA receipt to decision across Ackrad Laboratories's cleared 510(k)s is 48 days.
What devices does Ackrad Laboratories make?
Its most frequent FDA product codes are LKF (Cannula, Manipulator/Injector, Uterine, 6); BSY (Catheters, Suction, Tracheobronchial, 4); BZD (Ventilator, Non-Continuous (Respirator), 4).
Has Ackrad Laboratories had device recalls?
openFDA lists no recalls under a recalling firm name matching Ackrad Laboratories. Related entities may recall under other names.
Next steps
- See all 42 Ackrad Laboratories clearances with predicates and recalls
- Run predicate analysis for product code LKF, Ackrad Laboratories'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.