# Keeler Instruments, Inc.

- Location (FDA's records): Broomall, PA
- FDA decisions: 60 (1981–2019): 60 510(k) clearances
- Product codes: HLI (6), HKX (5), GZX (4), HRM (4), HNN (4), HQF (3), HLJ (3), HRN (3), HMP (2), HPS (2), HJO (2), HPQ (2)
- Predicates its devices cite: 6 (5 its own); citations of its devices by later devices: 17 (5 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
- Kowa Co., Ltd.: 1 (https://510kreport.com/company/kowa)

## Firms that cite its devices most
- Phakos: 2 (https://510kreport.com/company/phakos)
- Keeler Limited: 2 (https://510kreport.com/company/keeler)
- Tearscience, Inc.: 1 (https://510kreport.com/company/tearscience)
- Pentax Precision Instrument Corp.: 1 (https://510kreport.com/company/pentax-precision-instrument)
- Heine Optotechnik GmbH & Co. KG: 1 (https://510kreport.com/company/heine-optotechnik)
- Ophthalmic Imaging Systems: 1 (https://510kreport.com/company/ophthalmic-imaging-systems)
- Dutch Ophthalmic USA, Inc.: 1 (https://510kreport.com/company/dutch-ophthalmic-usa)
- Iridex Corp: 1 (https://510kreport.com/company/iridex)

## Its most-cited devices
- K112093: Cryomatic Cryo Console, Disposable Cryo Probe, Disposable Probe Adapter (2011), cited by 2
- K973064: Keeler Tearscope-Plus (1998), cited by 2
- K062412: Cryomatic (2006), cited by 2
- K992954: Keeler Cryo Master & Probes (1999), cited by 2
- K093298: Pulsair Intellipuff, Pulsair Desktop Model 2414-P-2001, 2417-P-2000 (2010), cited by 2
- K874555: Keeler Acu 22XT Ophthalmic Cryo Unit (1988), cited by 1

## Recent decisions
- K181143: Keeler TonoCare Tonometer (Feb 8, 2019)
- K112093: Cryomatic Cryo Console, Disposable Cryo Probe, Disposable Probe Adapter (Dec 8, 2011)
- K093298: Pulsair Intellipuff, Pulsair Desktop Model 2414-P-2001, 2417-P-2000 (Dec 10, 2010)
- K100500: PSL Classic Slit Lamp (Mar 9, 2010)
- K062412: Cryomatic (Nov 6, 2006)
- K060822: Vantage Indirect Ophthalmoscope (May 23, 2006)
- K032087: Keeler Wide Angle Ophthalmoscope Model 1130-P-5004 (Nov 26, 2003)
- K992954: Keeler Cryo Master & Probes (Dec 21, 1999)

Source page: https://510kreport.com/company/keeler-instruments