Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JDY — Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
22 daysmedian FDA review time
234 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K902167 | CONTAIN(TM) LASER PLUME FILTER | Arbor Technologies, Inc. | 1991-01-04 | 234 | 0 |
| K902056 | LASER TRAP 100 LASER PLUME SMOKE EVACUATION FILTER | Hollister, Inc. | 1990-10-30 | 176 | 0 |
| K862509 | CHARCOAL LASER SMOKE FILTER CATALOG NO. 901103-000 | Lifestream Int'L, Inc. | 1986-07-23 | 22 | 0 |
| K810542 | CEMENT FUME EVACUATOR TANK & FILTER | Walgen Medical Innoventions | 1981-03-13 | 14 | 0 |
| K790877 | BIOVAC: LFA LASER FUME (SMOKE) EVACUATIO | Stackhouse Assoc. | 1979-05-23 | 16 | 0 |
| K780202 | MONOMER EVACUATION SYSTEM | Medishield, Inc. | 1978-02-21 | 14 | 0 |
| K770690 | MASK, VAPOR, MONOMER | Howmedica Corp. | 1977-07-21 | 99 | 0 |
| K760906 | MONOMER VAPOR CONTAINMENT SYSTEM | Howmedica Corp. | 1976-11-11 | 16 | 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