Cleared Traditional

K170305 - Spinal Manometer NRFit

Also marketed or referenced as:
Spinal Manometer LUER

K170305 is an FDA 510(k) clearance for Spinal Manometer NRFit, manufactured by PAJUNK GmbH Medizintechnologie. The device is a Class 2 General Hospital device with product code FMJ cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K170305 · PAJUNK GmbH Medizintechnologie · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2017
Decision
175d
Days
Class 2
Risk

K170305 is an FDA 510(k) clearance for the Spinal Manometer NRFit. Classified as Manometer, Spinal-fluid (product code FMJ), Class II - Special Controls.

Submitted by PAJUNK GmbH Medizintechnologie (Geisingen, DE). The FDA issued a Cleared decision on July 25, 2017 after a review of 175 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2500 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all PAJUNK GmbH Medizintechnologie devices

FDA 510(k) Submission Details - K170305

510(k) Number K170305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2017
Decision Date July 25, 2017
Days to Decision 175 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 129d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMJ Device Classification - Class 2, Special Controls

Product Code FMJ Manometer, Spinal-fluid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2500
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FMJ Manometer, Spinal-fluid

Devices cleared under the same product code (FMJ) and FDA review panel - the closest regulatory comparables to K170305.
BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER
K032432 · Busse Hospital Disposables, Inc. · Aug 2003
LUMBAR PUNCTURE KIT
K970287 · B.Braun Medical, Inc. · Apr 1997
SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22)
K963570 · Smiths Industries Medical Systems, Inc. · Oct 1996
MEGA LUMBAR PUNCTURE KIT
K910089 · Megadyne Medical Products, Inc. · Jun 1991