# Penlon, Inc.

- Location (FDA's records): Mchenry, IL
- FDA decisions: 22 (1980–2006): 22 510(k) clearances
- Names in FDA's records: Penlon, Inc. (10); Penlon , Ltd. (9); Penlon Limited (3)
- Product codes: CAD (9), CAP (3), BSZ (3), CBK (2), CCW (1), BSF (1), CCL (1), DWJ (1), BZK (1)
- Predicates its devices cite: 10 (4 its own); citations of its devices by later devices: 7 (4 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Datex-Ohmeda, Inc.: 2 (https://510kreport.com/company/datex-ohmeda)
- Ohmeda Medical: 1 (https://510kreport.com/company/ohmeda-medical)
- Draeger Medical, Inc.: 1 (https://510kreport.com/company/draeger-medical)
- Bear Medical Systems, Inc.: 1 (https://510kreport.com/company/bear-medical-systems)
- Southmedic, Inc.: 1 (https://510kreport.com/company/southmedic)

## Firms that cite its devices most
- Thornhill Research, Inc.: 1 (https://510kreport.com/company/thornhill-research)
- Piramal Critcal Care, Inc (Formerly Minrad, Inc): 1 (https://510kreport.com/company/piramal-critcal-care-formerly-minrad)
- Dre Medical, Inc.: 1 (https://510kreport.com/company/dre-medical)

## Its most-cited devices
- K002343: Sigma Delta (2001), cited by 2
- K844008: Penlon AM1000 Anaesthesia Machine (1985), cited by 1
- K010318: Prima Oxygen Monitor (2001), cited by 1
- K061102: Prima Anaesthesia Machine (2006), cited by 1
- K010317: AV 800 Ventilator (2001), cited by 1
- K053564: Keyed Filler Bottle Adaptor, Models 53450, 53452, 53453, 53454 (2006), cited by 1

## Recent decisions
- K061102: Prima Anaesthesia Machine (Jul 28, 2006)
- K060331: Sigma Alpha Vaporizer (May 10, 2006)
- K053564: Keyed Filler Bottle Adaptor, Models 53450, 53452, 53453, 53454 (Mar 3, 2006)
- K051222: AV-S Anaesthesia Ventilator (Sep 23, 2005)
- K041076: Delta T (Aug 9, 2004)
- K010318: Prima Oxygen Monitor (Jul 23, 2001)
- K010317: AV 800 Ventilator (Jul 23, 2001)
- K002343: Sigma Delta (Jun 8, 2001)

Source page: https://510kreport.com/company/penlon