Humidi-Flex TM

FDA 510(k) K885313 · Life Design Systems, Inc.

Substantially Equivalent

510(k) numberK885313

Submission

Device name
Humidi-Flex TM
Applicant
Life Design Systems, Inc.
Franklin, WI, US
Received
December 29, 1988
Decision date
October 11, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
BYD – Condenser, Heat And Moisture (Artificial Nose)
Device class
Class I (low risk)
Regulation
21 CFR 868.5375
Specialty
Anesthesiology

Other 510(k)s with product code BYD

510(k)DeviceApplicantDecision
K955008Heat & Moisture ExchangerBYD · Traditional Intertech Resources, Inc.01/30/1996SE
K954194Disposable Hme/FilterBYD · Traditional Engstrom Medical10/20/1995SE
K953580Heat Moisture ExchangerBYD · Traditional Intertech Resources, Inc.09/15/1995SE
K953507Type 1 & 2 (Humidair I & II)BYD · Traditional Icor AB09/07/1995SE
K953620Warm N Wet Hmef W/Luer AdapterBYD · Traditional Hospitak, Inc.08/25/1995SE
K953619Warm N Wet Hme W/Luer AdapterBYD · Traditional Hospitak, Inc.08/25/1995SE
K953544Humid-Vent 2 Light/Humid-Vent 2 Port LightBYD · Traditional Gibeck, Inc.08/25/1995SE
K953540EeeBYD · Traditional Edentec Corp.08/25/1995SE
K953491Humid-Vent 1 Port/Humid-Vent 1 Port AngleBYD · Traditional Gibeck, Inc.08/25/1995SE
K952845Humid-Vent Trach-VentBYD · Traditional Gibeck, Inc.07/25/1995SE

More from Gibeck, Inc.

510(k)DeviceDecision
K913714Modification Manual Pulmon Resuscitor/Pulmanex(Tm)BTM · Traditional 12/01/1992SE
K893030Child Size - Filter Flex (TM)CAH · Traditional 09/18/1989SE
K892862Flex-Cup PercussorBYI · Traditional 05/25/1989SE
K892221Pulmonary Resuscitator, ModificationBTM · Traditional 05/18/1989SE
K890011Oxygen Connector and Oxygen Delivery TubingBZO · Traditional 03/20/1989SE
K890108Modified Cushion-Flex(Tm)BSJ · Traditional 01/24/1989SE
K884387Cushion Flex(Tm)BSJ · Traditional 11/17/1988SE
K884068Pulmanex TM (Neo-Natal Size)BTM · Traditional 11/16/1988SE
K873179Heater Wire Breathing CircuitBZE · Traditional 03/31/1988SE
K863857Pulse-OxDQA · Traditional 10/07/1987SE

Questions and answers

When was Humidi-Flex TM cleared by the FDA?

Humidi-Flex TM (K885313) received a 510(k) decision of Substantially Equivalent on October 11, 1989, 286 days after the submission was received.

What is the product code of K885313?

The FDA product code is BYD – Condenser, Heat And Moisture (Artificial Nose), a Class I (low risk) device regulated under 21 CFR 868.5375.