Shippert Medical Technologies Corp.: FDA clearances and approvals
Shippert Medical Technologies Corp. has 13 FDA 510(k) clearances (first 1995, latest 2010), across 7 product codes in 5 review panels. Median 510(k) review time: 44 days. openFDA lists 15 product recalls by a recalling firm named Shippert Medical Technologies Corp.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EMX | Balloon, Epistaxis | 5 | 5 |
| KYZ | Syringe, Irrigating (Non Dental) | 2 | 2 |
| MUU | System, Suction, Lipoplasty | 2 | 2 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| GEC | Brush, Scrub, Operating-Room | 1 | 1 |
| HOZ | Sponge, Ophthalmic | 1 | 1 |
| LYG | Massager, Therapeutic, Manual | 1 | 1 |
Review panels
- Ear, Nose and Throat (5)
- General and Plastic Surgery (4)
- General Hospital (2)
- Ophthalmic (1)
- Physical Medicine (1)
Most recent Shippert Medical Technologies Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K102117 | TISSU TRANS FILTRON SYRINGE FILL | MUU | 2010-08-06 | 9 |
| K092482 | TISSU TRANS FILTRON, MODELS 3-TT-FILTRON 2000-500 | MUU | 2009-12-04 | 113 |
| K092022 | TISSU TRANS HARVEST TUBING | KYZ | 2009-08-17 | 42 |
| K050797 | TISSU-TRANS | KYZ | 2005-07-13 | 106 |
| K964855 | EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIELD | HOZ | 1997-03-04 | 90 |
| K964334 | EXPANDACELL ANTI-FOG INSTRUMENT WIPE (WITH ALCOHOL)/(WITHOUT) | GCJ | 1996-12-09 | 39 |
| K963704 | MUSCLE WAND, A DEVICE FOR DEEP PRESSURE MUSCLE MASSAGE | LYG | 1996-11-26 | 71 |
| K962133 | EXPANDACELL INJECTO-PAK | EMX | 1996-08-01 | 59 |
| K960621 | EXPANDACELL INSTRUMENT WIPE | GEC | 1996-04-01 | 48 |
| K960228 | EXPANDACELL INJECTO-PAK NASAL PACK | EMX | 1996-02-27 | 41 |
3 earlier clearances. See the full list in Caduvo.
Recalls
15 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2018-02-02.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Shippert Medical Technologies Corp. have?
Shippert Medical Technologies Corp. has 13 FDA 510(k) clearances (first 1995, latest 2010), across 7 product codes in 5 review panels.
How long does FDA take to clear Shippert Medical Technologies Corp.'s 510(k)s?
The median time from FDA receipt to decision across Shippert Medical Technologies Corp.'s cleared 510(k)s is 44 days.
What devices does Shippert Medical Technologies Corp. make?
Its most frequent FDA product codes are EMX (Balloon, Epistaxis, 5); KYZ (Syringe, Irrigating (Non Dental), 2); MUU (System, Suction, Lipoplasty, 2).
Has Shippert Medical Technologies Corp. had device recalls?
openFDA lists 15 product recalls in 3 recall events by a recalling firm whose name matches Shippert Medical Technologies Corp; the most recent began 2018-02-02. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 13 Shippert Medical Technologies Corp. clearances with predicates and recalls
- Run predicate analysis for product code EMX, Shippert Medical Technologies Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.