Cleared Traditional

K854008 - STATLOCK

K854008 is an FDA 510(k) clearance for STATLOCK, manufactured by Healthtek, Inc.. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K854008 · Healthtek, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1985
Decision
44d
Days
Class 2
Risk

K854008 is an FDA 510(k) clearance for the STATLOCK. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Healthtek, Inc. (Nevada City, US). The FDA issued a Cleared decision on November 13, 1985 after a review of 44 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Healthtek, Inc. devices

FDA 510(k) Submission Details - K854008

510(k) Number K854008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1985
Decision Date November 13, 1985
Days to Decision 44 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 129d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LHI Device Classification - Class 2, Special Controls

Product Code LHI Set, I.v. Fluid Transfer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - LHI Set, I.v. Fluid Transfer

All 75
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K854008.
AUTOMIX 3+3 COMPOUNDER
K894827 · Baxter Healthcare Corp · Oct 1989
MODIFIED SLIDING RECONSTITUTION DEVICE
K884626 · Baxter Healthcare Corp · Nov 1988
MODIFIED HC-417 BAG TO BAG & HC-418 BOTTLE TO BAG
K861434 · Churchill Corp. · May 1986
SLIDING RECONSTITUTION DEVICE W/ADMIX VIALEX PLAST
K853830 · Travenol Laboratories, S.A. · Nov 1985
VIAL VENT FILTER
K852467 · Baxter Healthcare Corp · Oct 1985
TRANSFER DEVICE
K853188 · Advance Medical Designs, Inc. · Aug 1985