Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cambridge Heart, Inc. — Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
61 daysmedian FDA review time
221 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K100362 | CAMBRIDGE HEART OEM | Cambridge Heart, Inc. | 2010-04-14 | 61 | 0 |
| K050225 | HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM | Cambridge Heart, Inc. | 2005-04-07 | 65 | 0 |
| K022152 | HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS | Cambridge Heart, Inc. | 2002-07-16 | 14 | 0 |
| K022149 | CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000 | Cambridge Heart, Inc. | 2002-07-16 | 14 | 0 |
| K013564 | MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL | Cambridge Heart, Inc. | 2001-11-21 | 26 | 0 |
| K013565 | CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000 | Cambridge Heart, Inc. | 2001-11-21 | 26 | 0 |
| K012206 | ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYS | Cambridge Heart, Inc. | 2001-10-12 | 91 | 0 |
| K011324 | CAMBRIDGE HEART MODEL CH 2000 CARDIAC DIAGNOSTIC SYSTEM | Cambridge Heart, Inc. | 2001-05-23 | 22 | 0 |
| K010756 | CH 2000 CARDIAC DIAGNOSTIC SYSTEM | Cambridge Heart, Inc. | 2001-04-12 | 30 | 0 |
| K010758 | HEARTWAVE ALTERNANS PROCESSING SYSTEM, APS | Cambridge Heart, Inc. | 2001-04-12 | 30 | 0 |
| K003492 | ANALYTIC SPECTRAL METHOD OF ALTERNANS PROCESSING; CH 2000 CA | Cambridge Heart, Inc. | 2001-01-18 | 66 | 0 |
| K002230 | CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002 | Cambridge Heart, Inc. | 2000-08-18 | 25 | 1 |
| K001034 | MODEL APS ALTERNANS PROCESSING SYSTEM | Cambridge Heart, Inc. | 2000-06-09 | 70 | 0 |
| K983102 | CARDIAC DIAGNOSTIC SYSTEM MODEL CH 2000 | Cambridge Heart, Inc. | 1999-04-12 | 221 | 0 |
| K981697 | CAMBRIDGE HEART CH 2000 CARDIAC DIAGNOSTIC SYSTEM | Cambridge Heart, Inc. | 1998-10-14 | 156 | 0 |
| K962115 | CAMBRIDGE HEART HI-RES ECG ELECTRODE | Cambridge Heart, Inc. | 1996-08-29 | 90 | 0 |
| K950018 | CAMBRIDGE HEART CH 2000 STRESS TEST SYSTEM | Cambridge Heart, Inc. | 1996-02-29 | 422 | 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