Kit Pak, Inc.
Elk Grove Village, IL, US
Kit Pak, Inc. appears in FDA device records in Elk Grove Village, IL. FDA records list 13 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for Kit Pak, Inc. between 1989 and 1995. The busiest year on record is 1993, with 6. The most recent is 1995, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 2 |
| 1990 | 1 |
| 1993 | 6 |
| 1994 | 3 |
| 1995 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K942959 | KIT PAK WET SALINE DRESSING | FRO | Substantially Equivalent for Some Indications | |
| K941499 | KIT PAK DRESSING CHANGE TRAY | KGX | Unknown | |
| K932310 | KIT PAK INCONTINENT SKIN CARE KIT | EYQ | Unknown | |
| K934080 | URINARY DRAINAGE BAG | EYT | Substantially Equivalent | |
| K931013 | FOLEY CATHETER TRAY | KNY | Substantially Equivalent | |
| K923905 | WOUND DRESSING KIT | MCY | Unknown | |
| K924051 | KIT PAK I.V. START KIT | LYY | Unknown | |
| K923906 | FOLEY INSERTION TRAY | KOD | Unknown | |
| K922051 | KIT PAK'S FLUSHING KIT | KOD | Unknown | |
| K925281 | KIT PAK URINARY CARE SUPPLIES | KNY | Unknown | |
| K900148 | KIT PAK IRRIGATION TRAY | EYN | Unknown | |
| K890570 | SKIN SCRUB KIT | LRO | Substantially Equivalent | |
| K885131 | KIT PAK SUCTION CATHETER KIT | BSY | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KNYAccessories, Catheter, G-U
- KODCatheter, Urological
- BSYCatheters, Suction, Tracheobronchial
- FRODressing, Wound, Drug
- EYQGarment, Protective, For Incontinence
- LROGeneral Surgery Tray
- LYYLatex Patient Examination Glove
- EYTSheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile
- KGXTape And Bandage, Adhesive
- EYNTray, Irrigation, Sterile
- MCYWound Dressing Kit
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain