Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Syntermed, Inc. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
77 daysmedian FDA review time
87 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K130902 | EMORY CARDIAC TOOLBOX 3.2 | Syntermed, Inc. | 2013-06-14 | 74 | 0 |
| K130451 | NEUROQ 3.6 | Syntermed, Inc. | 2013-05-17 | 84 | 0 |
| K123646 | EMORY CARDIAC TOOLBOX 4.0 | Syntermed, Inc. | 2013-02-22 | 87 | 0 |
| K072307 | QUANTITATIVE NEUROQ 3.0 | Syntermed, Inc. | 2008-03-14 | 210 | 0 |
| K071503 | SYSTEM, TOMOGRAPHY, COMPUTED EMISSION | Syntermed, Inc. | 2007-07-26 | 55 | 0 |
| K070089 | SYNTERMED LIVE | Syntermed, Inc. | 2007-03-02 | 52 | 0 |
| K042258 | BP-SPECT V1.O | Syntermed, Inc. | 2004-10-04 | 45 | 0 |
| K041022 | NEUROQ - PET DP | Syntermed, Inc. | 2004-06-17 | 58 | 0 |
| K040141 | EMORY CARDIAC TOOLBOX VERSION 2.6 | Syntermed, Inc. | 2004-01-30 | 8 | 0 |
| K020300 | NORTHWESTERN GATED BLOOD POOL SPECT (NUMUGAS) | Syntermed, Inc. | 2002-04-23 | 84 | 0 |
| K014033 | EMORY CARDIAC TOOLBOX 2.1 EXECUTING ON NUCLEAR MEDICINE COMP | Syntermed, Inc. | 2002-02-22 | 77 | 0 |
| K001276 | MEDICAL IMAGE MERGE (MIM) | Syntermed, Inc. | 2000-07-17 | 87 | 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