Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ivy Biomedical Systems, Inc. · Predicate Candidate Screening
27 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
136 daysmedian FDA review time
287 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240087 | RT Carbon ECG Leads | Ivy Biomedical Systems, Inc. | 2024-09-13 | 246 | 0 |
| K202138 | Cardiac Trigger Monitor | Ivy Biomedical Systems, Inc. | 2021-05-14 | 287 | 0 |
| K203653 | MRI PPG Patient Cable | Ivy Biomedical Systems, Inc. | 2021-03-02 | 77 | 0 |
| K192852 | MRI ECG Patient Cable | Ivy Biomedical Systems, Inc. | 2020-03-28 | 177 | 0 |
| K171778 | MR Wireless Gating System, Model WGS-100 | Ivy Biomedical Systems, Inc. | 2018-03-14 | 272 | 0 |
| K170828 | Cardiac Trigger Monitor | Ivy Biomedical Systems, Inc. | 2017-05-17 | 58 | 0 |
| K151781 | Cardiac Trigger Monitor, Cardiac & Regulatory Synchronizatio | Ivy Biomedical Systems, Inc. | 2016-05-27 | 331 | 0 |
| K110987 | CARDIAC TRIGGER MONITOR | Ivy Biomedical Systems, Inc. | 2011-07-22 | 105 | 0 |
| K091787 | MODEL 6000 TWO PARAMETER BEDSIDE MONITOR | Ivy Biomedical Systems, Inc. | 2009-10-09 | 114 | 0 |
| K091985 | UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE | Ivy Biomedical Systems, Inc. | 2009-07-24 | 22 | 0 |
| K083854 | CARDIAC TRIGGER, MODEL: CTM300 | Ivy Biomedical Systems, Inc. | 2009-02-13 | 51 | 0 |
| K023616 | PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES) | Ivy Biomedical Systems, Inc. | 2002-11-04 | 6 | 0 |
| K982255 | MODEL 2000 PULSE OXIMETER | Ivy Biomedical Systems, Inc. | 1998-10-22 | 118 | 0 |
| K964961 | MODEL 405T WITH ETCO2 OPTION | Ivy Biomedical Systems, Inc. | 1997-05-14 | 154 | 0 |
| K955546 | PATIENT MONITOR MODEL 405P | Ivy Biomedical Systems, Inc. | 1996-08-16 | 255 | 0 |
| K945099 | PARAMETERS MONITORES | Ivy Biomedical Systems, Inc. | 1995-07-13 | 268 | 0 |
| K912139 | MODEL 704 | Ivy Biomedical Systems, Inc. | 1992-03-25 | 316 | 0 |
| K904606 | MODEL 405 | Ivy Biomedical Systems, Inc. | 1991-03-01 | 142 | 0 |
| K901504 | MODELS 706 ECG/PRESSURE/RESP./SAO2, 705 ECG/RESP. | Ivy Biomedical Systems, Inc. | 1990-08-23 | 147 | 0 |
| K884455 | MODEL 702 ECG/RESPIRATION/TEMPERATURE | Ivy Biomedical Systems, Inc. | 1989-03-09 | 136 | 0 |
| K884096 | PATIENT MONITOR MODEL 701 | Ivy Biomedical Systems, Inc. | 1989-02-23 | 148 | 0 |
| K884662 | PATIENT MONITOR MODEL 703 | Ivy Biomedical Systems, Inc. | 1989-02-02 | 87 | 0 |
| K882118 | MODEL 700 PATIENT MONITOR | Ivy Biomedical Systems, Inc. | 1988-08-02 | 75 | 0 |
| K882188 | MODEL 404 ADULT HEART RATE/BLOOD PRESSURE MONITOR | Ivy Biomedical Systems, Inc. | 1988-07-28 | 65 | 0 |
| K880066 | MODEL 303D AND 403D ADULT HEART RATE & RESPIRATOR | Ivy Biomedical Systems, Inc. | 1988-03-22 | 71 | 0 |
| K862647 | PHYSIOLOGICAL MONITOR, MODELS 401,402 & 403 | Ivy Biomedical Systems, Inc. | 1986-08-18 | 38 | 0 |
| K854840 | PHYSIOLOGICAL MONITOR, MODELS 101,301,201,202,303A | Ivy Biomedical Systems, Inc. | 1986-05-07 | 154 | 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