# Accutome, Inc.

- Location (FDA's records): Malvern, PA
- FDA decisions: 8 (1981–2015): 8 510(k) clearances
- Product codes: IYO (5), HKY (1), IYN (1), HOE (1)
- Predicates its devices cite: 12 (2 its own); citations of its devices by later devices: 4 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Accutome Ultrasound, Inc.: 4 (https://510kreport.com/company/accutome-ultrasound)
- Teknar, Inc.: 2 (https://510kreport.com/company/teknar)
- Mentor Ophthalmics, Inc.: 1 (https://510kreport.com/company/mentor-ophthalmics)
- Dgh Technology, Inc.: 1 (https://510kreport.com/company/dgh-technology)
- Oculab, Inc.: 1 (https://510kreport.com/company/oculab)
- Opko Instrumentation, Inc.: 1 (https://510kreport.com/company/opko-instrumentation)

## Firms that cite its devices most
- Accutome Ultrasound, Inc.: 1 (https://510kreport.com/company/accutome-ultrasound)
- Haag-Streit AG: 1 (https://510kreport.com/company/haag-streit)

## Its most-cited devices
- K032956: Accusonic a-Scan  Model, 24-4000 (2003), cited by 2
- K123349: A-Scan Plus Connect (2013), cited by 1
- K810660: Kremer Corneometer Ultrasonic Pachometer (1981), cited by 1

## Recent decisions
- K152573: 4Sight (Nov 25, 2015)
- K132549: Accutip Cover (Apr 23, 2014)
- K123349: A-Scan Plus Connect (Jan 29, 2013)
- K103471: Ubm Plus (Mar 14, 2011)
- K050552: Pachpen Pachymeter, Model 24-5100 (Mar 28, 2005)
- K032956: Accusonic a-Scan  Model, 24-4000 (Oct 10, 2003)
- K820050: Kremer Blade Gauge (Feb 24, 1982)
- K810660: Kremer Corneometer Ultrasonic Pachometer (Aug 21, 1981)

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