510(k) Report

510(k) · Cleared

Cleared

Dyna-Flex Multi-Layer Compression System

K970721510(k) TraditionalCleared Mar 21, 199722-day reviewClass II21 CFR 880.5075

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Johnson & Johnson Medical, Inc. · MCY Wound Dressing Kit

Cleared on Mar 21, 1997 after a 22-day review. The FDA summary names its predicate without a number.

Decided
Mar 21, 1997
Review
22 days
Class
Class II
Product code
MCY
Recalls
None
Predicates
0

The FDA summary names its predicate without a number.

FIG. 1 — Lineage of K970721Source: FDA 510(k) database · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MCY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*—Wound Care Compression System (WCCS)
Named without a submission number
—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All MCY devices

MCY Wound Dressing Kit: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MCY

FDA has decided no MCY device since 2007.

Median 510(k) review, days · MCY

Too few MCY 510(k)s in any year since 2007 to give a median.

Recalls per year · MCY

1in 2024

2007: 192009: 32011: 452014: 3, 3 Class I2023: 2, 1 Class I2024: 12026 (partial year): 7, 1 Class I
2007high 45 (2011) · low 0 (2008)2026

Class I (5 since 2007) Class II/III not classified

Adverse event reports per year · MCY

3in 2025

2012: 32014: 12015: 22019: 12020: 92021: 32024: 102025: 3
2007high 10 (2024) · low 0 (2007)2025

MAUDE reports naming product code MCY, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—190
20080—00
20090—30
20100—00
20110—450
20120—03
20130—00
20140—3 (3)1
20150—02
20160—00
20170—00
20180—00
20190—01
20200—09
20210—03
20220—00
20230—2 (1)0
20240—110
20250—03
20260—7 (1)—

What is it indicated for?

DYNA-FLEX* Multi-Layer Compression System is indicated for the management of venous leg ulcers and related conditions. The compression system may be used on patients with an ankle circumference of 18 cm or larger (padded). Compression data indicates that the DYNA-FLEX* Multi-Layer Compression System provides sustained compression for up to seven days at both the ankle and below the knee, when used according to package insert directions. The DYNA-FLEX…

Read the full statement (113 words)

DYNA-FLEX* Multi-Layer Compression System is indicated for the management of venous leg ulcers and related conditions. The compression system may be used on patients with an ankle circumference of 18 cm or larger (padded). Compression data indicates that the DYNA-FLEX* Multi-Layer Compression System provides sustained compression for up to seven days at both the ankle and below the knee, when used according to package insert directions.

The DYNA-FLEX Multi-Layer Compression System should not be used on diabetic patients with advanced small vessel disease, patients with lymphadema as a result of cancer, or on patients with an ankle:brachial index (ABI) of less than 0.8 . Doppler ultrasound is recommended to rule out arterial disease.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Johnson & Johnson Medical, Inc.

54 FDA decisions under this applicant name. See the company

  • K001690Protectiv Safety Blood Collection NeedleJohnson & Johnson Medical, Inc. · 2000
  • K982641Advanced Nibp ModuleJohnson & Johnson Medical, Inc. · 1999
  • K983362NU-Gel * Wound DressingJohnson & Johnson Medical, Inc. · 1998
  • K982597Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc. · 1998
  • K974080Critikon Soft Blood Pressure CuffJohnson & Johnson Medical, Inc. · 19981 recall

Recent decisions in MCY

The MCY category page

  • K963719Central Line Dressing Change Tray, TPN/CVP Dressing Change TrayGrand Medical Products · 1996
  • K960585Wound Care Compression System (WCCS)Suncoast Medical Products, Inc. · 1996
  • K952334Dressing Change TrayBusse Hospital Disposables, Inc. · 1995
  • K951022Circulon System Step 1Convatec, A Division of E.R. Squibb & Sons · 1995
  • K951021Circulon System Step 2Convatec, A Division of E.R. Squibb & Sons · 1995

https://510kreport.com/device/K970721 · printed Nov 5, 2026

Cite this page

510(k) Report. “K970721: Dyna-Flex Multi-Layer Compression System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970721

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026