Inflatable Air Splints
FDA 510(k) K853600 · Hospitak, Inc.
510(k) numberK853600
Submission
- Device name
- Inflatable Air Splints
- Applicant
- Hospitak, Inc.
Lindenhurst, NY, US - Received
- August 27, 1985
- Decision date
- September 19, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FZF – Splint, Extremity, Inflatable, External
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.3900
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FZF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K881516 | CompresaidFZF · Traditional | R. Evans Corp. | 04/29/1988SE |
| K874053 | Inflatable Full Arm SplintFZF · Traditional | Vinyl Technology, Inc. | 11/23/1987SE |
| K874052 | Inflatable Half Leg SplintFZF · Traditional | Vinyl Technology, Inc. | 11/23/1987SE |
| K874051 | Inflatable Full Leg SplintFZF · Traditional | Vinyl Technology, Inc. | 11/23/1987SE |
| K874050 | Inflatable Foot & Ankle SplintFZF · Traditional | Vinyl Technology, Inc. | 11/23/1987SE |
| K831764 | Urias Pressure Splints, & First AidFZF · Traditional | Svenol Andersen | 09/12/1983SE |
More from Svenol Andersen
| 510(k) | Device | Decision |
|---|---|---|
| K955483 | Trach Mask Model (245, 246)BYF · Traditional | 02/28/1996SE |
| K954787 | IlluminatorCCW · Traditional | 01/31/1996SE |
| K953620 | Warm N Wet Hmef W/Luer AdapterBYD · Traditional | 08/25/1995SE |
| K953619 | Warm N Wet Hme W/Luer AdapterBYD · Traditional | 08/25/1995SE |
| K915750 | Disposable Bacterial Breathng FilterCAH · Traditional | 11/30/1994SE |
| K920842 | Aerosol Delivery SystemsLRD · Traditional | 05/15/1992SE |
| K915228 | Disposable CO2 Gas Sampling/Oxygen Delivery CannulCCK · Traditional | 02/11/1992SE |
| K873286 | Disposable, Manual Pulmonary ResuscitatorBTM · Traditional | 10/26/1987SE |
| K844328 | Oxygen ConcentratorCAW · Traditional | 12/04/1984SE |
| K843212 | Low Pressure Alarm for Oxygen CylinderBXH · Traditional | 09/19/1984SE |
Questions and answers
When was Inflatable Air Splints cleared by the FDA?
Inflatable Air Splints (K853600) received a 510(k) decision of Substantially Equivalent on September 19, 1985, 23 days after the submission was received.
What is the product code of K853600?
The FDA product code is FZF – Splint, Extremity, Inflatable, External, a Class I (low risk) device regulated under 21 CFR 878.3900.