Aesculap, Inc.: FDA clearances and approvals
Aesculap, Inc. has 218 FDA 510(k) clearances (first 1991, latest 2025), across 74 product codes in 9 review panels. Median 510(k) review time: 90 days. Since 2017 its median was 154 days, against 106 days for all cleared 510(k)s in the same product codes. openFDA lists 44 product recalls by a recalling firm named Aesculap, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 5 | 103 |
| 2013 | 4 | 179 |
| 2014 | 5 | 91 |
| 2015 | 7 | 151 |
| 2016 | 3 | 289 |
| 2017 | 6 | 150 |
| 2018 | 6 | 247 |
| 2019 | 6 | 140 |
| 2020 | 6 | 32 |
| 2021 | 3 | 206 |
| 2022 | 1 | 372 |
| 2023 | 1 | 209 |
| 2024 | 1 | 160 |
| 2025 | 1 | 243 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Aesculap, Inc.'s cleared 510(k)s took a median 154 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 106 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 18 | 18 |
| GCJ | Laparoscope, General & Plastic Surgery | 14 | 14 |
| JXG | Shunt, Central Nervous System And Components | 13 | 13 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 13 | 13 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 11 | 11 |
| HCH | Clip, Aneurysm | 10 | 10 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 7 | 7 |
| GWG | Endoscope, Neurological | 7 | 7 |
| FRG | Wrap, Sterilization | 6 | 6 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 6 | 6 |
Plus 64 more product codes.
Review panels
- General and Plastic Surgery (70)
- Neurology (63)
- Orthopedic (51)
- General Hospital (21)
- Obstetrics and Gynecology (4)
- Cardiovascular (3)
- Gastroenterology and Urology (3)
- Dental (2)
- Radiology (1)
Most recent Aesculap, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242762 | Aesculap Aicon® Series Container System | KCT | 2025-05-13 | 243 |
| K242003 | XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set | JXG | 2024-12-16 | 160 |
| K223596 | SQ.line KERRISON | HAE | 2023-06-29 | 209 |
| K214041 | Aesculap AICON Container | KCT | 2022-12-30 | 372 |
| K211572 | Aesculap Slim Clip Applier | HCI | 2021-12-13 | 206 |
| K203739 | ELAN 4 Electro Motor System | HBE | 2021-08-24 | 245 |
| K202391 | DIR 800 | IZI | 2021-01-21 | 153 |
| K203461 | Aesculap Caiman 12 Seal and Cut Technology System | GEI | 2020-12-18 | 24 |
| K202938 | Aesculap Caiman 5 Seal and Cut Technology System | GEI | 2020-10-30 | 30 |
| K202124 | Aesculap PAS-Port Proximal Anastomosis System | FZP | 2020-09-02 | 33 |
208 earlier clearances. See the full list in Caduvo.
Recalls
44 product recalls in 28 recall events; 18 initiated in the last five years. Most recent: 2026-01-15.
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 Aesculap, Inc. have?
Aesculap, Inc. has 218 FDA 510(k) clearances (first 1991, latest 2025), across 74 product codes in 9 review panels.
How long does FDA take to clear Aesculap, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Aesculap, Inc.'s cleared 510(k)s is 90 days. Since 2017: 154 days, versus 106 days for all cleared 510(k)s in the same product codes.
What devices does Aesculap, Inc. make?
Its most frequent FDA product codes are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 18); GCJ (Laparoscope, General & Plastic Surgery, 14); JXG (Shunt, Central Nervous System And Components, 13).
Has Aesculap, Inc. had device recalls?
openFDA lists 44 product recalls in 28 recall events by a recalling firm whose name matches Aesculap, Inc; the most recent began 2026-01-15. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 218 Aesculap, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Aesculap, 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.