Product Code: FMJ FDA class 2 21 CFR 880.2500

Manometer, Spinal-Fluid

General Hospital

The Spinal-Fluid Manometer is a device used during lumbar puncture procedures to measure cerebrospinal fluid pressure by connecting to a spinal needle and displaying the fluid column height. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FMJ, regulated under 21 CFR 880.2500 in the General Hospital specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

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Basic Information

Product Code: FMJ
Device Class: FDA class 2
Regulation Number: 880.2500
Medical Specialty: General Hospital
Review Panel: HO
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 6 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K170305	Spinal Manometer NRFit; Spinal Manometer LUER	Jul 25, 2017	Substantially Equivalent	PAJUNK GmbH Medizintechnologie
K032432	BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER	Aug 28, 2003	Substantially Equivalent	Busse Hospital Disposables, Inc.
K970287	LUMBAR PUNCTURE KIT	Apr 07, 1997	Substantially Equivalent	B.Braun Medical, Inc.
K963570	SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22)	Oct 18, 1996	Substantially Equivalent	Smiths Industries Medical Systems, Inc.
K910089	MEGA LUMBAR PUNCTURE KIT	Jun 20, 1991	Unknown	Megadyne Medical Products, Inc.
K882405	HYPODERMIC NEEDLE SHEATH HOLDER	Jun 29, 1988	Substantially Equivalent	Ansr Ent., Inc.