Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shippert Medical Technologies Corp. — Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
44 daysmedian FDA review time
106 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K102117 | TISSU TRANS FILTRON SYRINGE FILL | Shippert Medical Technologies Corp. | 2010-08-06 | 9 | 0 |
| K092482 | TISSU TRANS FILTRON, MODELS 3-TT-FILTRON 2000-500 | Shippert Medical Technologies Corp. | 2009-12-04 | 113 | 0 |
| K092022 | TISSU TRANS HARVEST TUBING | Shippert Medical Technologies Corp. | 2009-08-17 | 42 | 0 |
| K050797 | TISSU-TRANS | Shippert Medical Technologies Corp. | 2005-07-13 | 106 | 0 |
| K964855 | EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIE | Shippert Medical Technologies Corp. | 1997-03-04 | 90 | 0 |
| K964334 | EXPANDACELL ANTI-FOG INSTRUMENT WIPE (WITH ALCOHOL)/(WITHOUT | Shippert Medical Technologies Corp. | 1996-12-09 | 39 | 0 |
| K963704 | MUSCLE WAND, A DEVICE FOR DEEP PRESSURE MUSCLE MASSAGE | Shippert Medical Technologies Corp. | 1996-11-26 | 71 | 0 |
| K962133 | EXPANDACELL INJECTO-PAK | Shippert Medical Technologies Corp. | 1996-08-01 | 59 | 0 |
| K960621 | EXPANDACELL INSTRUMENT WIPE | Shippert Medical Technologies Corp. | 1996-04-01 | 48 | 0 |
| K960228 | EXPANDACELL INJECTO-PAK NASAL PACK | Shippert Medical Technologies Corp. | 1996-02-27 | 41 | 0 |
| K955593 | EXPANDACELL ANATOMICAL POSTERIOR NASAL PACK W/& WITHOUT AIRW | Shippert Medical Technologies Corp. | 1995-12-22 | 15 | 0 |
| K954845 | EXPANDACELL INJECTO-PAK NASAL PACK | Shippert Medical Technologies Corp. | 1995-11-27 | 35 | 0 |
| K950024 | EXPANDACELL NASAL PACK WITH AIRWAY | Shippert Medical Technologies Corp. | 1995-02-17 | 44 | 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