FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BODAI SUCTION -SAFE 4
K Number: K811241
·
Decision May 27, 1981
Classifications
1
FEI Numbers
245
Registration Numbers
245
Same Product Code
115
Applicant Total
7
Review Days
23
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
- BODAI SUCTION -SAFE 4
- K Number
- K811241
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.6810
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Sontek Industries, Inc.
- Date Received
- May 4, 1981
- Decision Date
- May 27, 1981
- Product Code
- BSY
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BSY | Catheters, Suction, Tracheobronchial | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BSY), ordered by most recent decision date.
MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM
FDA 510(k)
FDA Class 1
·Anesthesiology
AMBU HAND POWER SUCTION PUMP
FDA 510(k)
FDA Class 1
·Anesthesiology
DUAL PURPOSE CLOSED CATHETER
FDA 510(k)
FDA Class 1
·Anesthesiology
SUCTION CATHETER
FDA 510(k)
FDA Class 1
·Anesthesiology
HI-CARE CLOSED SUCTION SYSTEM
FDA 510(k)
FDA Class 1
·Anesthesiology
AMSINO SUCTION CATHETER
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Sontek Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K833373 | BODIA BRONCH-SAF DOUBLE SWIVEL | Nov 3, 1983 | Substantially Equivalent |
| K833372 | BODIA TRACH-SAF DOUBLE SWIVEL | Nov 3, 1983 | Substantially Equivalent |
| K833361 | TUBE-TITLE | Nov 3, 1983 | Substantially Equivalent |
| K833374 | BITE-BLOCK | Nov 3, 1983 | Substantially Equivalent |
| K813324 | BODAI SWIVEL Y | Dec 29, 1981 | Substantially Equivalent |
| K812720 | BODAI PATIENT COMMUNICATOR | Nov 5, 1981 | Substantially Equivalent |