Title 21, Part 880 — General Hospital and Personal Use Devices

Scope.

Effective dates of requirement for premarket approval.

Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Liquid crystal forehead temperature strip.

Bed-patient monitor.

Electronic monitor for gravity flow infusion systems.

Electrically powered spinal fluid pressure monitor.

Spinal fluid manometer.

Stand-on patient scale.

Patient scale.

Surgical sponge scale.

Image processing device for estimation of external blood loss.

Sterilization process indicator.

Clinical color change thermometer.

Clinical electronic thermometer.

Clinical mercury thermometer.

Apgar timer.

I.V. container.

Medical recirculating air cleaner.

Elastic bandage.

Liquid bandage.

AC-powered adjustable hospital bed.

Hydraulic adjustable hospital bed.

Manual adjustable hospital bed.

Infant radiant warmer.

Pediatric medical crib.

Medical bassinet.

Nonpowered flotation therapy mattress.

Therapeutic medical binder.

Burn sheet.

Intravascular catheter.

Intravascular catheter securement device.

Intravenous catheter force-activated separation device.

Medical adhesive tape and adhesive bandage.

Neonatal eye pad.

Medical absorbent fiber.

Neonatal incubator.

Neonatal transport incubator.

Pressure infusor for an I.V. bag.

Nonelectrically powered fluid injector.

Intravascular administration set.

Intravascular administration set, automated air removal system.

Patient care reverse isolation chamber.

Jet lavage.

AC-powered patient lift.

Non-AC-powered patient lift.

Alternating pressure air flotation mattress.

Temperature regulated water mattress.

Hypodermic single lumen needle.

Acupuncture needle.

Nipple shield.

Lamb feeding nipple.

Pediatric position holder.

Neonatal phototherapy unit.

Infusion pump.

Alternate controller enabled infusion pump.

Suction snakebite kit.

Chemical cold pack snakebite kit.

Medical support stocking.

Therapeutic scrotal support.

Piston syringe.

Umbilical occlusion device.

Lice removal kit.

Subcutaneous, implanted, intravascular infusion port and catheter.

Percutaneous, implanted, long-term intravascular catheter.

Absorbent tipped applicator.

Ice bag.

Medical disposable bedding.

Bed board.

Cardiopulmonary resuscitation board.

Hot/cold water bottle.

Ethylene oxide gas aerator cabinet.

Medical chair and table.

Ultrasonic cleaner for medical instruments.

[Reserved]

Cast cover.

Mattress cover for medical purposes.

Ring cutter.

Sharps needle destruction device.

Tongue depressor.

Non-powdered patient examination glove.

Filtering facepiece respirator for use by the general public in public health medical emergencies.

Examination gown.

Medical insole.

Implantable radiofrequency transponder system for patient identification and health information.

Ingestible event marker.

Medical device data system.

Remote Medication Management System.

AC-powered medical examination light.

Battery-powered medical examination light.

Patient lubricant.

Liquid medication dispenser.

Skin pressure protectors.

Medical ultraviolet air purifier.

Ultraviolet (UV) radiation chamber disinfection device.

Medical ultraviolet water purifier.

Body waste receptacle.

Vacuum-powered body fluid suction apparatus.

Protective restraint.

Powered patient transfer device.

Manual patient transfer device.

Washers for body waste receptacles.

Medical disposable scissors.

Sterilization wrap.

Ethylene oxide gas sterilizer.

Dry-heat sterilizer.

Steam sterilizer.

Liquid chemical sterilants/high level disinfectants.

Spore test strip.

General purpose disinfectants.

Hand-carried stretcher.

Wheeled stretcher.

Syringe needle introducer.

Irrigating syringe.

Liquid crystal vein locator.

Vein stabilizer.

Infusion stand.

Medical washer.

Medical washer-disinfector.