Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Intersect Medical Products, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
35 daysmedian FDA review time
40 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K945543 | GAMGRO ENGSTROM Y FILTER WITH EDITH FLEX (1500 F), EDIT 500, | Intersect Medical Products, Inc. | 1994-11-29 | 15 | 0 |
| K792516 | RESPIRATOR DISCONNECT ALARM CR 201 | Intersect Medical Products, Inc. | 1980-01-09 | 35 | 0 |
| K792515 | RESPIRATOR DISCONNECT ALARM | Intersect Medical Products, Inc. | 1980-01-09 | 35 | 0 |
| K791527 | RESPIRATOR DISCONNECT ALARM CR201 | Intersect Medical Products, Inc. | 1979-09-19 | 40 | 0 |
| K791561 | RESPIRATOR DISCONNECT ALARM VA-100 | Intersect Medical Products, Inc. | 1979-09-19 | 35 | 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