Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Packaging Corp. · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
79 daysmedian FDA review time
459 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K003761 | NAT - NUCLEIC ACID TRANSPORT | Medical Packaging Corp. | 2001-05-31 | 176 | 0 |
| K972726 | SNAP SWAB CULTURE COLLECTION AND TRANSPORT SYSTEM | Medical Packaging Corp. | 1997-10-08 | 79 | 0 |
| K970597 | CULTURE-PAK COLLECTION AND TRANSPORT SYSTEM WITH CLINICAL TR | Medical Packaging Corp. | 1997-03-24 | 34 | 0 |
| K964637 | CULTURE COLLECTION AND TRANSPORT SYSTEM, MODIFIED AMIES MEDI | Medical Packaging Corp. | 1996-12-24 | 35 | 0 |
| K936078 | CULTURE-PAK COLLECTION/TRANSPORT SYSTEM, MODIFIED | Medical Packaging Corp. | 1994-08-16 | 326 | 0 |
| K932337 | CULTURE-PAK COLLECTION AND TRANSPORT SYSTEM | Medical Packaging Corp. | 1994-08-16 | 459 | 0 |
| K915454 | CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT | Medical Packaging Corp. | 1992-04-08 | 125 | 0 |
| K881105 | CULTURE COLLECTION DEVICE | Medical Packaging Corp. | 1988-04-25 | 41 | 0 |
| K870398 | PAP-PAK CYTOBRUSH KIT | Medical Packaging Corp. | 1987-02-25 | 23 | 0 |
| K864323 | CYTOLOGY BRUSHES | Medical Packaging Corp. | 1987-01-09 | 67 | 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