Cleared Traditional

K000438 - MULTI LUMEN SUCTION SYRINGE SPRAY DISPENSER

K000438 is an FDA 510(k) clearance for MULTI LUMEN SUCTION SYRINGE SPRAY DISPENSER, manufactured by Biosurgical Corp.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K000438 · Biosurgical Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
83d
Days
Class 2
Risk

K000438 is an FDA 510(k) clearance for the MULTI LUMEN SUCTION SYRINGE SPRAY DISPENSER. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Biosurgical Corp. (Pleasanton, US). The FDA issued a Cleared decision on May 3, 2000 after a review of 83 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 Biosurgical Corp. devices

FDA 510(k) Submission Details - K000438

510(k) Number K000438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2000
Decision Date May 03, 2000
Days to Decision 83 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 129d · This submission: 83d
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 389
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K000438.
TISSOMAT AND SPRAY SET
K981089 · Baxter Healthcare Corp · Jul 2000
TERUMO U-100 INSULIN SYRING
K001474 · Terumo Medical Corp. · Jun 2000
THE WAND
K992404 · Spintech, Inc. · Jun 2000
HAEMACURE HEMAMYST SURGICAL APPLICATOR SYSTEM H-AS01
K994023 · Haemacure Corp. · Apr 2000
ULTICARE DISPOSABLE SYRINGE
K994230 · Ultimed, Inc. · Mar 2000
PROFI DISPOSABLE SYRINGE, PROFI DISPOSABLE NEEDLE, DM JECT INSULIN SYRINGE
K993017 · Shinchang Medical Co., Ltd. · Feb 2000