Cleared Traditional

K894217 - SYRINGE TIP ADAPTOR

K894217 is an FDA 510(k) clearance for SYRINGE TIP ADAPTOR, manufactured by Acacia, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K894217 · Acacia, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1989
Decision
85d
Days
Class 2
Risk

K894217 is an FDA 510(k) clearance for the SYRINGE TIP ADAPTOR. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Acacia, Inc. (Loma Linda, US). The FDA issued a Cleared decision on September 12, 1989 after a review of 85 days - a notably fast clearance cycle.

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: 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 Acacia, Inc. devices

FDA 510(k) Submission Details - K894217

510(k) Number K894217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1989
Decision Date September 12, 1989
Days to Decision 85 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 129d · This submission: 85d
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 429
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K894217.
INTOPO
K894206 · Acacia, Inc. · Oct 1989
30-CS01, 30-CS02, 30-CS03 CONTROL SYRINGES
K894801 · Advance Medical Designs, Inc. · Sep 1989
NEEDLE*LESS DRUG VIAL ADAPTER
K894177 · Baxter Healthcare Corp · Sep 1989
MODEL #535 PACU STRETCHER/BED & #530 ED/TRAUMA STR
K894335 · Midmark Corp. · Sep 1989
DISPENSING PIN/CHEMOTHERAPY DISPENSING PIN
K890082 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1989
CONTROL SYRINGE
K884497 · Professional Medical Services · Dec 1988