Barrier Pediatric/Incise Drape 450

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K780839 ↗

FDA Product Code

KKX

Device Class

Class II

Regulation

21 CFR Part 878.4370

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Edge Protector, Barrier

  Class II

  FDA 510(k) K790306 Active Cleared 22 Feb 1979

• Barrier General Surgery Pack

  Class II

  FDA 510(k) K760807 Active Cleared 3 Nov 1976

• Barrier Antimicrobial Incise Drape

  Class II

  FDA 510(k) K820543 Active Cleared 22 Jul 1982

• Purge Line Unit

  Class II

  FDA 510(k) K790804 Active Cleared 25 May 1979

• Sterile Surgical Scrub Brush

  Class I

  FDA 510(k) K874653 Active Cleared 30 Dec 1987

• Drapes, Barrier, Sterile Patient Ready

  Class II

  FDA 510(k) K760212 Active Cleared 11 Aug 1976

See all devices from Surgikos, Inc. →

• What is the Barrier Pediatric/Incise Drape 450 used for?

  The Barrier Pediatric/Incise Drape 450 is designed specifically for pediatric surgical procedures to create a sterile barrier between the patient and the surgical field. Its purpose is to minimize contamination risk during the incision and draping phases, protecting both the patient and the surgical team from potential pathogens. This makes it ideal for operating rooms and other controlled surgical environments where maintaining sterility is critical.

• Is the Barrier Pediatric/Incise Drape 450 reusable or single-use?

  The Barrier Pediatric/Incise Drape 450 is intended for single-use only. This design choice ensures sterility and reduces the risk of cross-contamination between patients, aligning with best practices for surgical drapes in clinical settings.

• What are the key features of the Barrier Pediatric/Incise Drape 450?

  The drape is sterile, disposable, and designed exclusively for pediatric surgical procedures. Its primary function is to act as a protective barrier during incision and draping, helping to maintain a sterile field. The product is categorized under FDA product code KKX, indicating its classification as a surgical drape.

• How is the Barrier Pediatric/Incise Drape 450 supplied?

  The drape is supplied in a sterile, single-use packaging to ensure it remains uncontaminated until use. This packaging is designed to maintain sterility until the drape is opened in a controlled surgical environment, such as an operating room.

• What regulatory pathway does the Barrier Pediatric/Incise Drape 450 follow?

  The Barrier Pediatric/Incise Drape 450 received FDA 510(k) clearance under the Traditional review pathway, with a decision date of August 14, 1978. This clearance indicates that the device was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets regulatory standards for safety and effectiveness.