Data / Medical devices / United States / Pepper Medical, Inc.
Pepper Medical, Inc.: FDA-registered device maker in West Chester, PA, United States, 2 510(k) clearances
Pepper Medical, Inc. is registered with the FDA (registration 2529776) in West Chester, PA, United States. It lists 11 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 13, 2004. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 2529776
- FEI number
- 1000121196
- Address
- 600 W Strasburg Rd, West Chester, PA, United States, 19382
- Owner or operator
- PEPPER MEDICAL, INC. (9006041)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- November 2, 2001
- Registered through
- 2027
- Brand names listed
- AVALON AIRE HEADSTRAP, Bacterial Viral Filter, Closed Suction Catheter, ENDO-TIE, Endo-Tie, PreVent Endo Holder, Foley Loc, Foley Tube Holder, Foley-Patch and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bag, Reservoir | BTC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Binder, Abdominal | FSD | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Catheters, Suction, Tracheobronchial | BSY | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Condenser, Heat And Moisture (Artificial Nose) | BYD | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Device, Fixation, Tracheal Tube | CBH | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Filter, Bacterial, Breathing-Circuit | CAH | 2 | Repackager or relabeler | accessdata.fda.gov |
| Holder, Ureteral Catheter | EYJ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Strap, Head, Gas Mask | BTK | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Support, Breathing Tube | JAY | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 13, 2004 | K033008 | AIR SAFETY HEPA AND NON-HEPA FILTERS | CAH | Substantially Equivalent | Air Safety, Ltd. | accessdata.fda.gov |
| June 14, 1985 | K851070 | RESP-BAC BACTERIA FILTER | CAH | Substantially Equivalent | Medicomp, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Strap, Head, Gas Mask
- All makers of Bag, Reservoir
- All makers of Device, Fixation, Tracheal Tube
- All makers of Set, Tubing And Support, Ventilator (W Harness)
- All makers of Holder, Ureteral Catheter
- All makers of Filter, Bacterial, Breathing-Circuit
Updated May 13, 2004. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.