Cleared Traditional

K160978 - LITe BIO Delivery System

K160978 is an FDA 510(k) clearance for LITe BIO Delivery System, manufactured by Stryker Corporation. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K160978 · Stryker Corporation · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
92d
Days
Class 2
Risk

K160978 is an FDA 510(k) clearance for the LITe BIO Delivery System. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Stryker Corporation (Allendale, US). The FDA issued a Cleared decision on July 8, 2016 after a review of 92 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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.

FDA 510(k) Submission Details - K160978

510(k) Number K160978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2016
Decision Date July 08, 2016
Days to Decision 92 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
37d faster than avg
Panel avg: 129d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 - FMF Syringe, Piston

All 598
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K160978.
InPen
K160629 · Companion Medical, Inc. · Jul 2016
SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE
K152803 · Sung Shim Medicare Co., Ltd. · Jul 2016
BD U-500 INSULIN SYRINGE
K151870 · Becton, Dickinson and Company · Jul 2016
Sol-M Insulin Syringe, Sol-M TB Syringe
K153537 · Sol-Millennium Medical, Inc. · Jun 2016
HumaPen Savvio
K160668 · Eli Lilly and Company, Inc. · Jun 2016
SiO2 Coated syringe 3 ml
K153553 · Sio2 Medical Products · May 2016
K160978 · LITe BIO Delivery System
Download PDF FDA Summary Stryker Corporation