Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Aesculap, Inc. — Predicate Candidate Screening
207 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
277 days90th percentile
207clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242762 | Aesculap Aicon® Series Container System | Aesculap, Inc. | 2025-05-13 | 243 | 0 |
| K242003 | XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Ca | Aesculap, Inc. | 2024-12-16 | 160 | 0 |
| K223596 | SQ.line KERRISON | Aesculap, Inc. | 2023-06-29 | 209 | 0 |
| K214041 | Aesculap AICON Container | Aesculap, Inc. | 2022-12-30 | 372 | 0 |
| K211572 | Aesculap Slim Clip Applier | Aesculap, Inc. | 2021-12-13 | 206 | 0 |
| K203739 | ELAN 4 Electro Motor System | Aesculap, Inc. | 2021-08-24 | 245 | 0 |
| K202391 | DIR 800 | Aesculap, Inc. | 2021-01-21 | 153 | 0 |
| K203461 | Aesculap Caiman 12 Seal and Cut Technology System | Aesculap, Inc. | 2020-12-18 | 24 | 0 |
| K202938 | Aesculap Caiman 5 Seal and Cut Technology System | Aesculap, Inc. | 2020-10-30 | 30 | 0 |
| K202124 | Aesculap PAS-Port Proximal Anastomosis System | Aesculap, Inc. | 2020-09-02 | 33 | 0 |
| K200950 | Ventricular Catheter | Aesculap, Inc. | 2020-05-08 | 29 | 0 |
| K192056 | JJ Series Container System | Aesculap, Inc. | 2020-03-27 | 239 | 0 |
| K193582 | SterilContainer S2 System | Aesculap, Inc. | 2020-03-17 | 85 | 0 |
| K192266 | M. Blue Adjustable Shunt System | Aesculap, Inc. | 2019-11-21 | 92 | 0 |
| K183203 | ELAN 4 Tools | Aesculap, Inc. | 2019-08-09 | 263 | 0 |
| K182414 | Aesculap® SterilContainer(TM) S2 System | Aesculap, Inc. | 2019-07-05 | 304 | 0 |
| K190174 | Miethke Shunt System GAV 2.0 and SA 2.0 Valves | Aesculap, Inc. | 2019-07-05 | 154 | 0 |
| K183180 | Caiman 5 Maryland | Aesculap, Inc. | 2019-03-12 | 113 | 1 |
| K182527 | ELAN 4 Tools | Aesculap, Inc. | 2019-01-19 | 127 | 0 |
| K182032 | SterilContainer S System | Aesculap, Inc. | 2018-12-21 | 144 | 0 |
| K172907 | ELAN 4 Air Motor System | Aesculap, Inc. | 2018-11-09 | 410 | 2 |
| K172709 | ELAN 4 Electro Motor System Tools | Aesculap, Inc. | 2018-10-17 | 404 | 0 |
| K180914 | Aesculap Slim Clip Applier | Aesculap, Inc. | 2018-04-17 | 8 | 0 |
| K180321 | Aesculap Optilene Nonabsorbable Suture | Aesculap, Inc. | 2018-03-07 | 30 | 0 |
| K170683 | Aesculap Video Assisted Thoracic Surgery (VATS) INstruments | Aesculap, Inc. | 2018-02-20 | 350 | 0 |
| K172850 | SterilContainer with PrimeLine Pro Lid | Aesculap, Inc. | 2017-11-17 | 58 | 0 |
| K173271 | Aesculap Slim Clip Applier Forceps | Aesculap, Inc. | 2017-11-10 | 29 | 0 |
| K171001 | Monosyn Quick Synthetic Absorbable Surgical Suture | Aesculap, Inc. | 2017-10-23 | 202 | 0 |
| K162815 | SterilContainer S System | Aesculap, Inc. | 2017-07-13 | 280 | 0 |
| K170661 | Novosyn Quick Absorbable Suture | Aesculap, Inc. | 2017-06-08 | 97 | 0 |
| K161853 | proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shun | Aesculap, Inc. | 2017-02-27 | 236 | 0 |
| K152960 | ELAN 4 Motor System | Aesculap, Inc. | 2016-07-22 | 289 | 0 |
| K160393 | AdTec | Aesculap, Inc. | 2016-05-26 | 105 | 0 |
| K151165 | Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture | Aesculap, Inc. | 2016-02-17 | 292 | 0 |
| K151865 | PremiPatch PTFE Pledget | Aesculap, Inc. | 2015-10-27 | 111 | 0 |
| K151242 | SterilContainer S | Aesculap, Inc. | 2015-10-09 | 151 | 0 |
| K143729 | SterilContainer S | Aesculap, Inc. | 2015-08-18 | 232 | 0 |
| K151858 | Caiman Seal and Cut Technology | Aesculap, Inc. | 2015-07-21 | 13 | 1 |
| K151696 | Caiman Seal and Cut Technology | Aesculap, Inc. | 2015-07-20 | 27 | 0 |
| K142970 | SterilContainer S System | Aesculap, Inc. | 2015-07-08 | 267 | 0 |
| K141687 | AESCULAP - MEITHKE PROGAV 2.0 ADJUSTABLE SHUNT SYSTEM | Aesculap, Inc. | 2015-04-02 | 294 | 0 |
| K142315 | MINOP Disposable Introducer 26F | Aesculap, Inc. | 2014-11-14 | 87 | 0 |
| K133890 | AESCULAP OPTILENE NONABSORBABLE SUTURE | Aesculap, Inc. | 2014-07-15 | 207 | 0 |
| K140343 | AESCULAP HISTOACRYL, HISTOACRYL BLUE AND HISTOACRYL FLEXIBLE | Aesculap, Inc. | 2014-05-13 | 91 | 0 |
| K140839 | CAIMAN SEAL AND CUT TECHNOLOGY | Aesculap, Inc. | 2014-04-28 | 26 | 0 |
| K131500 | YASARGIL ANEURYSM CLIPS AND CLIP APPLIERS | Aesculap, Inc. | 2014-01-24 | 245 | 0 |
| K122791 | LYOPLANT ONLAY | Aesculap, Inc. | 2013-06-04 | 265 | 0 |
| K121976 | AESCULAP HISTOACRYL FLEXIBLE TOPICAL SKIN ADHESIVE | Aesculap, Inc. | 2013-05-17 | 316 | 0 |
| K130596 | CAIMAN SEAL AND CUT TECHNOLOGY | Aesculap, Inc. | 2013-03-22 | 15 | 0 |
| K123102 | SOVEREIGN MINI | Aesculap, Inc. | 2013-01-03 | 93 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda