Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
American Telecare, Inc. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
164 daysmedian FDA review time
444 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K030222 | NX SYSTEM | American Telecare, Inc. | 2003-08-19 | 209 | 0 |
| K003999 | AVIVA SYSTEM, MODEL SL 2020; AVIVA SLX SYSTEM SYSTEM, MODEL | American Telecare, Inc. | 2001-06-28 | 184 | 0 |
| K993550 | AVIVA SYSTEM, MODEL SL1010 | American Telecare, Inc. | 2000-01-13 | 85 | 0 |
| K981533 | AVIVA SYSTEMS MODEL NUMBERS 1010, 2020 | American Telecare, Inc. | 1998-07-15 | 77 | 0 |
| K973873 | DIGITAL PERSONAL TELEMEDICINE MODULE, DIGITAL PTM 1 | American Telecare, Inc. | 1997-12-29 | 80 | 0 |
| K963678 | CARETONE II | American Telecare, Inc. | 1997-02-24 | 164 | 0 |
| K964554 | PERSONAL TELEMEDICINE MODULE | American Telecare, Inc. | 1996-12-17 | 34 | 0 |
| K952882 | PERSONAL TELEMEDICINE SYSTEM | American Telecare, Inc. | 1996-09-09 | 444 | 0 |
| K945638 | TELPHONIC STETHOSCOPE | American Telecare, Inc. | 1995-05-17 | 182 | 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