510(k) Report

510(k) · Cleared

Cleared

Barrier Surgical Drapes

K051625510(k) SpecialCleared Jul 14, 200524-day reviewClass II21 CFR 878.4370

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

Molnlycke Health Care, Inc. · KKX Drape, Surgical, Antimicrobial

Cleared on Jul 14, 2005 as substantially equivalent to K760807 (Surgikos, Inc., 1976) and 11 other predicates after a 24-day review. Its family tree reaches back 1 generation to 1976.

Decided
Jul 14, 2005
Review
24 days
Class
Class II
Product code
KKX
Recalls
None
Predicates
12

Its longest line of descent runs back 1 generation to K760807 (1976). 12 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1978: 8 other ancestors1976: 3 other ancestorsK760807 · Barrier General Surgery Pack · Surgikos, Inc. · 19761975198019851990199520002005
Other ancestors, by generation 1 generation back: 11 other ancestors K760807 · Barrier General Surgery Pack · Surgikos, Inc. · 19760
  1. Root · 1 generation backK760807 Barrier General Surgery PackSurgikos, Inc. · 1976
  2. This deviceK051625 Barrier Surgical DrapesMolnlycke Health Care, Inc. · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K760807Barrier General Surgery PackSurgikos, Inc.1976—
0 (this device)K051625Barrier Surgical DrapesMolnlycke Health Care, Inc.2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197630
197880
FIG. 1 — Lineage of K051625, 1976–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Top candidate predicates for a new KKX device

  1. #1 K222578 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise…score 5.7 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (12)

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
*K760807Barrier General Surgery Pack
Summary page 1
…were pre-amendment devices manufactured by Johnson and Johnson Medical. The first premarket notifications (K760807, K760902, K760933, K760937) were submitted in 1976 to cover the products already on…
Surgikos, Inc.1976—
*K760902Barrier Under Buttocks Drape
Summary page 1
…were pre-amendment devices manufactured by Johnson and Johnson Medical. The first premarket notifications (K760807, K760902, K760933, K760937) were submitted in 1976 to cover the products already on the mark…
Surgikos, Inc.1976—
*K760933Barrier Universal Sheet
Summary page 1
…re pre-amendment devices manufactured by Johnson and Johnson Medical. The first premarket notifications (K760807, K760902, K760933, K760937) were submitted in 1976 to cover the products already on the market. In 19…
Surgikos, Inc.1976—
*K760937Barrier Neuro Sheet
Summary page 1
…tured by Johnson and Johnson Medical. The first premarket notifications (K760807, K760902, K760933, K760937) were submitted in 1976 to cover the products already on the market. In 1978, additional submissions (K780…
Surgikos, Inc.1976—
*K780282Barrier Hip Pack W/ Fabric 450
Summary page 1
…902, K760933, K760937) were submitted in 1976 to cover the products already on the market. In 1978, additional submissions (K780282, K780839A, K780840A, K780841A, K780842A, K780843A, K780844A, K780856A) were made fo…
Surgikos, Inc.19781
*K780839Barrier Pediatric/Incise Drape 450
Summary page 1
…K760937) were submitted in 1976 to cover the products already on the market. In 1978, additional submissions (K780282, K780839A, K780840A, K780841A, K780842A, K780843A, K780844A, K780856A) were made for modifications to the fabric…
Surgikos, Inc.1978—
*K780840Barrier Laparotomy Sheet 450
Summary page 1
…37) were submitted in 1976 to cover the products already on the market. In 1978, additional submissions (K780282, K780839A, K780840A, K780841A, K780842A, K780843A, K780844A, K780856A) were made for modifications to the fabric…
Surgikos, Inc.1978—
*K780841Barrier Medium Sheet 450
Summary page 1
…ubmitted in 1976 to cover the products already on the market. In 1978, additional submissions (K780282, K780839A, K780840A, K780841A, K780842A, K780843A, K780844A, K780856A) were made for modifications to the fabric…
Surgikos, Inc.1978—
*K780842Barrier Basic Pack Fabric 450
Summary page 1
…n 1976 to cover the products already on the market. In 1978, additional submissions (K780282, K780839A, K780840A, K780841A, K780842A, K780843A, K780844A, K780856A) were made for modifications to the fabric in variou…
Surgikos, Inc.1978—
*K780843Barrier Abdominal Pack Fabric 450
Summary page 1
…cover the products already on the market. In 1978, additional submissions (K780282, K780839A, K780840A, K780841A, K780842A, K780843A, K780844A, K780856A) were made for modifications to the fabric in various surgical…
Surgikos, Inc.1978—
*K780844Barrier Obstetrical Pack Fabric 450
Summary page 1
…the market. In 1978, additional submissions (K780282, K780839A, K780840A, K780841A, K780842A, K780843A, K780844A, K780856A) were made for modifications to the fabric in various surgical drape configurations to the Fabr…
Surgikos, Inc.1978—
*K780856Barrier Gynecology Pack Fabric 450
Summary page 1
…the market. In 1978, additional submissions (K780282, K780839A, K780840A, K780841A, K780842A, K780843A, K780844A, K780856A) were made for modifications to the fabric in various surgical drape configurations to the Fabric 450® no…
Surgikos, Inc.1978—

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.

What does this lineage say?

  • 1 of the 12 ancestors has a recall of any class.

How does its category compare?

All KKX devices

KKX Drape, Surgical, Antimicrobial: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KKX

2in 2023

2007: 42008: 52009: 52010: 82011: 42012: 22013: 32014: 62015: 22017: 12020: 12021: 12023: 2
2007high 8 (2010) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KKX

182in 2014

2007: 181 days median2008: 164 days median2009: 114 days median2010: 107 days median2011: 147 days median2013: 227 days median2014: 182 days median
2007high 227 (2013) · low 107 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KKX

2in 2024

2007: 12010: 12011: 12012: 12013: 72014: 7, 7 Class I2016: 42024: 22026 (partial year): 2
2007high 7 (2013) · low 0 (2008)2026

Class I (7 since 2007) Class II/III not classified

Adverse event reports per year · KKX

24in 2025

2007: 242008: 242009: 272010: 252011: 572012: 402013: 632014: 282015: 332016: 562017: 302018: 322019: 412020: 162021: 412022: 192023: 322024: 192025: 24
2007high 63 (2013) · low 16 (2020)2025

MAUDE reports naming product code KKX, 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
20074181124
20085164024
20095114027
20108107125
20114147157
20122—140
20133227763
201461827 (7)28
20152—033
20160—456
20171—030
20180—032
20190—041
20201—016
20211—041
20220—019
20232—032
20240—219
20250—024
20260—2—

What is it indicated for?

BARRIER® surgical drapes are intended for single use to be used as a protective patient covering, such as to isolate a site on a surgical incision from microbial and other contamination.

Indications for use as stated in the FDA summary.

More from Molnlycke Health Care, Inc.

10 FDA decisions under this applicant name. See the company

  • K062138Powder Free Sterile Nitrile Examination Gloves, Blue; Powder Free Polychloroprene Sterile Examination GloveMolnlycke Health Care, Inc. · 2006
  • K000902Klinidrape Reinforced Surgical GownsMolnlycke Health Care, Inc. · 2000
  • K000901Klinidrape Surgical Gowns, Non-Reinforced, Basic Protections and Standard ProtectionMolnlycke Health Care, Inc. · 2000
  • K000906Klinidrape Surgical DrapesMolnlycke Health Care, Inc. · 2000
  • K984371Mepitel Non Adherent Silicone DressingMolnlycke Health Care, Inc. · 1999

Recent decisions in KKX

The KKX category page

  • K230645BeneHold™ Surgical Incise Drape with CHG antimicrobial IIAvery Dennison Medical, Ltd. · 2023
  • K2225783M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)3M Company · 2023
  • K202208BeneHold Surgical Incise Drape with CHG antimicrobialAvery Dennison Belgie Bvba · 2021
  • K200238ControlRad Sterile CoverControlrad, Inc. · 2020
  • K163556MediClear PreOpCovalontechnologies, Inc. · 2017

https://510kreport.com/device/K051625 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051625: Barrier Surgical Drapes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051625

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