Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Livsmed, Inc. · Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
101 daysmedian FDA review time
277 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|
| K250126 | ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M | Livsmed, Inc. | 2025-10-21 | 277 | 0 |
| K241138 | ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSea | Livsmed, Inc. | 2024-11-15 | 205 | 0 |
| K240657 | ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-LH); | Livsmed, Inc. | 2024-06-06 | 90 | 0 |
| K230498 | ArtiSential Laparoscopic Instruments-Electrodes | Livsmed, Inc. | 2023-06-05 | 101 | 0 |
| K230539 | ArtiSential Laparoscopic Instruments-Electrodes | Livsmed, Inc. | 2023-04-27 | 59 | 0 |
| K230499 | ArtiSential Laparoscopic Instruments-Electrodes | Livsmed, Inc. | 2023-04-26 | 61 | 0 |
| K220384 | ArtiSential Laparoscopic Instruments-Electrodes | Livsmed, Inc. | 2022-02-24 | 14 | 0 |
| K212500 | ArtiSential Trocar | Livsmed, Inc. | 2021-12-03 | 116 | 0 |
| K203580 | ArtiSential Laparoscopic Instruments-Electrodes | Livsmed, Inc. | 2021-04-30 | 144 | 0 |
| K200875 | ArtiSential Laparoscopic Instruments - Electrodes | Livsmed, Inc. | 2020-06-17 | 77 | 0 |
| K200501 | ArtiSential Laparoscopic Instrument-Electrodes | Livsmed, Inc. | 2020-05-11 | 73 | 0 |
| K190909 | ArtiSential Bipolar Fenestrated Forceps | Livsmed, Inc. | 2020-02-13 | 311 | 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