# Sgarlato Laboratories, Inc.

- Location (FDA's records): San Jose, CA
- FDA decisions: 8 (1989–2005): 8 510(k) clearances
- Product codes: KWH (2), FRN (2), JDW (1), MJW (1), KQW (1), BXB (1)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 5 (1 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Burron Medical, Inc.: 1 (https://510kreport.com/company/burron-medical)
- I-Flow Corp.: 1 (https://510kreport.com/company/i-flow)

## Firms that cite its devices most
- Advanced Infusion, Inc.: 1 (https://510kreport.com/company/advanced-infusion)
- Ortho-Pro, LLC: 1 (https://510kreport.com/company/ortho-pro)
- New Deal, S.A.: 1 (https://510kreport.com/company/new-deal)
- Osteomed LP: 1 (https://510kreport.com/company/osteomed)

## Its most-cited devices
- K990101: Pain Control Infusion Pump (1999), cited by 2
- K982931: Threaded Fixation Pin (1998), cited by 1
- K905795: Sgarlato Flexible Hinge Toe Implant (1991), cited by 1
- K884739: Sgarlato Lesser Toe Implant (1989), cited by 1

## Recent decisions
- K043204: Sgarlato Labs Painfree Pump and Pain Control Infusion Pump (Mar 30, 2005)
- K990101: Pain Control Infusion Pump (Mar 19, 1999)
- K982931: Threaded Fixation Pin (Oct 21, 1998)
- K926262: First MPJ Continuous Passive Motion Device (Jan 26, 1994)
- K926237: O'brien Goniometer (Aug 2, 1993)
- K922292: Lundeen Subtalar Peg Implant (Oct 23, 1992)
- K905795: Sgarlato Flexible Hinge Toe Implant (May 29, 1991)
- K884739: Sgarlato Lesser Toe Implant (May 18, 1989)

Source page: https://510kreport.com/company/sgarlato-laboratories