Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
KOI — Predicate Candidate Screening
29 FDA 510(k) clearances under this product code; the 50 most recent screened below.
191 daysmedian FDA review time
439 days90th percentile
29clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261098 | TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Acce | Senzime AB | 2026-05-22 | 50 | 0 |
| K250887 | Neuromuscular Transmission Monitor TOF3D (2510091) | MIPM Mammendorfer Institut für Physik und Medizin GmbH | 2025-10-21 | 210 | 0 |
| K243339 | WiTOF | Idmed | 2025-06-23 | 241 | 0 |
| K242525 | iTOF® | Nerbio Medical Software Platforms, Inc. | 2024-12-05 | 101 | 0 |
| K220530 | Tetragraph Neuromuscular Transmission Monitor | Senzime AB | 2022-08-17 | 174 | 0 |
| K220976 | Life Scope PT BSM-1700 Series Bedside Monitor | Nihon Kohden Corporation | 2022-07-21 | 108 | 0 |
| K212434 | Neuromuscular Transmission Monitor TOF3D | MIPM Mammendorfer Institut für Physik und Medizin GmbH | 2022-05-05 | 274 | 0 |
| K213316 | Life Scope PT BSM-1700 Series, AY Series, Data Acquisition U | Nihon Kohden Corporation | 2021-12-29 | 86 | 0 |
| K201949 | Smart Cable NMT Module and Accessories, Life Scope BSM 3000 | Nihon Kohden Corporation | 2021-05-02 | 293 | 0 |
| K192958 | TwitchView System | Blink Device Company | 2020-04-02 | 163 | 0 |
| K190795 | Tetragraph Neuromuscular Transmission Monitor | Senzime AB | 2019-10-18 | 204 | 0 |
| K172690 | ToFscan | Idmed | 2018-05-31 | 267 | 0 |
| K172843 | TwitchView System | Blink Device Corporation | 2018-03-29 | 191 | 0 |
| K162048 | EZstim*III Peripheral Nerve Stimulator/Nerve Locator | Halyard Health - Irvine | 2016-12-05 | 133 | 0 |
| K051635 | DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT AN | GE Healthcare | 2005-07-15 | 25 | 1 |
| K042003 | INFINITY TRIDENT NMT POD | Draeger Medical Systems, Inc. | 2004-09-01 | 37 | 0 |
| K023342 | NEURO-TRACE III KIT, NEURO-TRACE III REGIONAL BLOCK CABLE, N | Hdc Corp. | 2004-03-02 | 512 | 0 |
| K002889 | PNS MAGNETIC STIMULATOR SYSTEM | Neotonus, Inc. | 2001-04-06 | 203 | 0 |
| K992596 | TOF-WATCH S | Organon Teknika Corp. | 1999-08-30 | 27 | 0 |
| K992598 | TOF-WATCH SX | Organon Teknika Corp. | 1999-08-30 | 27 | 0 |
| K972698 | TOF-WATCH | Organon Teknika Corp. | 1997-12-16 | 151 | 0 |
| K955026 | AS/3 NMT MODULE | Datex Medical Instrumentation, Inc. | 1997-04-28 | 543 | 1 |
| K955031 | MAXISTIM | Life-Tech Intl., Inc. | 1996-12-10 | 404 | 0 |
| K954505 | EZ STIM | Life-Tech Intl., Inc. | 1996-12-10 | 439 | 0 |
| K953205 | CONSTANT CURRENT PERIPHERAL NERVE STIMULATOR NS272 (MODIFICA | Fisher & Paykel Healthcare, Ltd. | 1996-05-23 | 359 | 0 |
| K925159 | TOF-GUARD TRANSMISSION MONITOR | Biometer Intl. A/S | 1993-09-01 | 323 | 0 |
| K924234 | CONS. CURRENT PERIPH. NERVE LOC. NS232,NS262,NS272 | Fisher & Paykel Electronics , Ltd. | 1993-05-27 | 276 | 0 |
| K861091 | EASISTIM | Promed Corp. | 1986-06-02 | 70 | 0 |
| K840108 | NEUROMUSCULAR TRANSMISSION MONITOR | Datex Division Instrumentarium Corp. | 1984-02-17 | 38 | 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