FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PEDICAT*
K Number: K810049
·
Decision Apr 21, 1981
Classifications
1
FEI Numbers
115
Registration Numbers
115
Same Product Code
48
Applicant Total
31
Review Days
98
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PEDICAT*
- K Number
- K810049
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6375
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Pollak (Intl.), Ltd.
- Date Received
- January 13, 1981
- Decision Date
- April 21, 1981
- Product Code
- KMJ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KMJ | Lubricant, Patient | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KMJ), ordered by most recent decision date.
Lubricating Jelly
FDA 510(k)
FDA Class 1
·General Hospital
COLONGLIDE LUBRICANT
FDA 510(k)
FDA Class 1
·General Hospital
COLONGLIDE(R) LUBRICANT
FDA 510(k)
FDA Class 1
·General Hospital
LUBE JELLY SURINGE
FDA 510(k)
FDA Class 1
·General Hospital
DUKAL LUBRICATING JELLY
FDA 510(k)
FDA Class 1
·General Hospital
STERILE LUBRICATING JELLY
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by Pollak (Intl.), Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K000227 | UMBICUT | Apr 27, 2000 | Substantially Equivalent |
| K810050 | VECAFIX* | Mar 26, 1981 | Substantially Equivalent |
| K802009 | FLOWCLAMP CAT.#1011 & 1012 | Oct 31, 1980 | Substantially Equivalent |
| K802011 | INFUSSION ALARM SYSTEM I.A.S. CAT.#1118 | Oct 31, 1980 | Substantially Equivalent |
| K802017 | DRESSING CHANGE SET CAT.#910-930 | Oct 10, 1980 | Substantially Equivalent |
| K802007 | PEDIWET=GUAZE IMPREGNATED WITH PETROL | Sep 26, 1980 | Substantially Equivalent |
| K801991 | PLASTIC FORCEPS CAT.#1001-1010 | Sep 16, 1980 | Substantially Equivalent |
| K801996 | GUAZE BANDAGES CAT.#101-169 | Sep 16, 1980 | Substantially Equivalent |
| K802021 | PEDIBAND CAT.#195-197 | Sep 16, 1980 | Substantially Equivalent |
| K802022 | STERILE GUAZE SWABS CAT.#301-420 | Sep 16, 1980 | Substantially Equivalent |