Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Porex Surgical, Inc. — Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
107 daysmedian FDA review time
336 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K102184 | MEDPOR CONTAIN CAN IMPLANT | Porex Surgical, Inc. | 2011-01-07 | 158 | 0 |
| K101835 | MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079 | Porex Surgical, Inc. | 2010-12-03 | 155 | 0 |
| K091807 | MEDPOR FIXATION SYSTEM | Porex Surgical, Inc. | 2010-06-28 | 375 | 0 |
| K091120 | MEDPOR CONTAIN IMPLANT | Porex Surgical, Inc. | 2010-03-19 | 336 | 0 |
| K083621 | MEDPOR CUSTOMIZED SURGICAL IMPLANT | Porex Surgical, Inc. | 2009-02-03 | 57 | 0 |
| K071335 | MEDPOR ATTRACTOR IMPLANT | Porex Surgical, Inc. | 2007-08-08 | 89 | 0 |
| K052297 | POREX ELECTROSURGERY NEEDLE | Porex Surgical, Inc. | 2006-03-28 | 217 | 0 |
| K040851 | MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM | Porex Surgical, Inc. | 2004-07-16 | 107 | 0 |
| K040364 | MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESH | Porex Surgical, Inc. | 2004-06-30 | 138 | 2 |
| K021357 | MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT | Porex Surgical, Inc. | 2002-08-05 | 98 | 1 |
| K012350 | MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL | Porex Surgical, Inc. | 2002-03-14 | 232 | 0 |
| K012108 | MEDPOR COATED TEAR DRAIN | Porex Surgical, Inc. | 2001-12-19 | 166 | 0 |
| K010902 | MEDPOR QUAD MOTILITY IMPLANT | Porex Surgical, Inc. | 2001-06-19 | 85 | 0 |
| K982040 | MEDPOR SURGICAL GRANULE IMPLANTS | Porex Surgical, Inc. | 1998-09-08 | 90 | 0 |
| K981374 | POREX NOSTRIL RETAINERS | Porex Surgical, Inc. | 1998-07-02 | 77 | 0 |
| K972034 | MEDPOR OCULAR CONFORMER | Porex Surgical, Inc. | 1998-01-20 | 232 | 1 |
| K954939 | MEDPOR OCULAR SCREW & ACCESSORIES | Porex Surgical, Inc. | 1996-01-25 | 87 | 0 |
| K952677 | MEDPOR BARRIER SURGICAL IMPLANT BIOMATERIAL | Porex Surgical, Inc. | 1995-08-21 | 70 | 2 |
| K943275 | MEDPOR SURGICAL IMPLANT MATERIAL | Porex Surgical, Inc. | 1994-09-02 | 57 | 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