# K971480: Duralastic I and Duralastic II

- Pathway: 510(k) (Traditional)
- Applicant: Allied Biomedical Corp.
- Decided: May 28, 1997 after 35 days
- Product code: MIB (Elastomer, Silicone Block)
- Device class: 2
- Regulation: 21 CFR 874.3620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Applied Biomaterial Technologies Duralastic Sheeting: named in the summary without a submission number
- (no number) Dow Corning Silastic Sheeting: named in the summary without a submission number

## Most influential descendants
- K973730: Durasil I and Durasil II (1997), 0 descendants of its own

## Indications for use
Duralastic I (Short Term) Nasal Splinting, Wound Dressings, wound drains, covering - for gastroschisis, suture bolsters, Scar Coverings, Laboratory Uses, Temporary facilitation of osteogenesis and guided tissue regeneration between the teeth and gingival margin, or external ear canal for example, temporary joint spacers and other short term uses according to the surgeon's determination. Duralastic I (Long Term) Nonreinforced - Tympanic Membrane Repair, Dural Covering .005inch, Nasal Septal Repair, Tendon Anastomosis, neural repair - .007inch. Correction of Strabismus .010inch, Galea Repair-.020inch, Orbital Floor Repair .040inch., Hemodialysis Shunt Anchors .060inch. Reinforced - Facilitation of Osteogenesis .007inch, repair of urethral strictures .007inch, Staged Repair of omphalocoel .020inch, Repair of Orbital Floor Fractures .040inch.

Source page: https://510kreport.com/device/K971480
Methodology: https://510kreport.com/methodology