# K021864: Primagard Nonsterile Femoral Angiography Drapes (Models PM1-0136, PM1-0119, PM1-0142)

- Pathway: 510(k) (Traditional)
- Applicant: Primeline Medical Products, Inc.
- Decided: Sep 23, 2002 after 109 days
- Product code: KKX (Drape, Surgical, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 878.4370
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K101598: Emm Surgical Drape SMS W/PE Sides Model 13-005 (with Minor Dimensional Variations for Alternate Configurations) (2010), 0 descendants of its own
- K042131: Promedical Surgical Drapes (2004), 0 descendants of its own

## Indications for use
The primaGARD Surgical Drapes are nonsterile Surgical Drape, identified in 21 CFR, part 878.4730, as a medical device intended to be used by operating room personnel during surgical procedures to protect both the surgical patients and the operating room personnel from the transfer of microorganisms, body fluids, and particulate material. The drapes are made of natural and/or synthetic material and used as a protective patient covering. One example of use of this drape is to isolate the site of surgical incision from particulate, microbial and other forms of contamination.

Source page: https://510kreport.com/device/K021864
Methodology: https://510kreport.com/methodology