Olympic Bili-Bassinet

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K971601 ↗

FDA Product Code

LBI

Device Class

Class II

Regulation

21 CFR Part 880.5700

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Olympic Smart Scale Care Center

  Class II

  FDA 510(k) K920423 Active Cleared 11 Jun 1992

• Olympic Medical Lectromed Cerebral Function Monitor System, Model 5330

  Class II

  FDA 510(k) K020335 Active Cleared 18 Jun 2002

• Lube-Lok

  Class I

  FDA 510(k) K781695 Active Cleared 1 Nov 1978

• Olympic Bili-Lite-Pad(Tm)

  Class II

  FDA 510(k) K901987 Active Cleared 16 Jul 1990

• Olympix Mini-Pasteurmatic (58210)

  Class II

  FDA 510(k) K972193 Active Cleared 5 Sep 1997

• Warm-Scale

  Class I

  FDA 510(k) K952649 Active Cleared 15 Aug 1995

See all devices from Olympic Medical Corp. →

• What is the Olympic Bili-Bassinet primarily used for in a clinical setting?

  The Olympic Bili-Bassinet Model 10 is designed specifically for neonatal phototherapy to treat newborns with jaundice. It combines a bassinet with integrated light therapy to safely reduce bilirubin levels in infants, making it ideal for general hospital neonatal care.

• Is the Olympic Bili-Bassinet reusable, and how should it be prepared for use?

  Yes, the Olympic Bili-Bassinet is supplied as a reusable medical device. It is not sterile upon delivery, so it must be thoroughly cleaned and maintained according to the manufacturer’s guidelines before each use to ensure safe and effective operation.

• What type of regulatory clearance does the Olympic Bili-Bassinet hold, and where was it submitted?

  The Olympic Bili-Bassinet holds FDA 510(k) clearance, classified as a Class II device under 21 CFR 880.5700. It was submitted to the FDA’s Orthopaedics and Rehabilitation Devices Advisory Committee (HO) and is intended for use in general hospital environments.

• Are there multiple models or sizes available for the Olympic Bili-Bassinet?

  The provided data only references the Olympic Bili-Bassinet Model 10, so no additional models or sizes are mentioned. However, the device is designed as a single integrated unit for neonatal phototherapy, ensuring consistency in treatment delivery.

• Does the Olympic Bili-Bassinet have any special storage or handling requirements?

  While specific storage instructions aren’t detailed in the data, as a reusable medical device, the Olympic Bili-Bassinet should be stored in a clean, dry environment to prevent contamination. Before each use, it must be cleaned and maintained per manufacturer guidelines to ensure proper functionality and safety.