Cleared Traditional

C-FLO SUCTION TUBE (K882121) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K882121 · Concept, Inc. · Cardiovascular device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Jun 1988

Decision

32d

Days

Class 2

Risk

K882121 is an FDA 510(k) clearance for the C-FLO SUCTION TUBE. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Concept, Inc. (Clearwater, US). The FDA issued a Cleared decision on June 20, 1988 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1120 - the FDA cardiovascular device oversight 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 Concept, Inc. devices

Submission Details

510(k) Number	K882121 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 19, 1988
Decision Date	June 20, 1988
Days to Decision	32 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

93d faster than avg

Panel avg: 125d · This submission: 32d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	DXQ Blood Pressure Cuff
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 870.1120
Definition	A Blood Pressure Cuff Is A Device That Has An Inflatable Bladder In An Elastic Sleeve (cuff) With A Mechanism For Inflating The Bladder. The Cuff Is Used To Determine A Subject's Blood Pressure.

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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DXQ Blood Pressure Cuff

All 45

Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K882121.

ADULT,STERILE,DISPOS.,NONIVAS.,BLOOD PRESS. CUFFS

K905147 · Hewlett-Packard Co. · Dec 1990

NEONATAL/STERILE/DISPOS/NONINVAS BLOOD PRESS CUFF

K905101 · Hewlett-Packard Co. · Dec 1990

HEWLETT-PACKARD SERIES OF DISPOSABLE NIBP CUFFS

K901252 · Hewlett-Packard Co. · Jul 1990

POROCOAT SCHATZKER II ACETABULUM

K852193 · Depuy, Inc. · Jul 1985

P.C.A. TOTAL HIP FEMORAL COMPONENT MODIFICATION

K852964 · Howmedica Corp. · Jul 1985

HOMEDICA CEMENTED ACETABULAR COMPONENT 6262

K851565 · Howmedica Corp. · Jul 1985

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K882121

Concept, Inc.

Clearwater, FL · US

MARTHA C MILLER

Regulatory profile

83 submissions 82 cleared

99% clearance rate · Active in Cardiovascular

Data Intelligence Layer

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

Verify on FDA.gov

510k Database

510(k) clearances indexed 175,450

Regulatory data since 1976

FDA monthly sync Active