510(k) Report

510(k) · Cleared

Cleared

Obf Model 115 Computer Tonometer System

K873422510(k) TraditionalCleared Nov 2, 198768-day reviewClass II21 CFR 886.1930

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ocular Blood Flow Laboratories, Inc. · HKX Tonometer, Ac-Powered

Cleared on Nov 2, 1987 after a 68-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Nov 2, 1987
Review
68 days
Class
Class II
Product code
HKX
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared2002: 1 descendant cleared1990200020102020
  1. This deviceK873422 Obf Model 115 Computer Tonometer SystemOcular Blood Flow Laboratories, Inc. · 1987
  2. Descendant · cites it directly · 1 of its ownK970887 Blood Flow AnalyzerParadigm Medical Industries, Inc. · 1997
  3. Descendant · 2 generations on · 0 of its ownK023245 Blood Flow Analyzer (Bfa), Model 408-100-01Paradigm Medical Industries, Inc. · 2002

Most influential descendants

Showing 2 of 2 · See all
  • K970887Blood Flow AnalyzerParadigm Medical Industries, Inc. · 1997 · cites it directly1descendant
  • K023245Blood Flow Analyzer (Bfa), Model 408-100-01Paradigm Medical Industries, Inc. · 2002 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K873422Obf Model 115 Computer Tonometer SystemOcular Blood Flow Laboratories, Inc.1987—
+1K970887Blood Flow AnalyzerParadigm Medical Industries, Inc.1997—
+2K023245Blood Flow Analyzer (Bfa), Model 408-100-01Paradigm Medical Industries, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200210
FIG. 1 — Lineage of K873422, 1987–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HKX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new HKX device

  1. #1 K253039 Auto Kerato-Refracto Tonometer TRK-3 Omniascore 11.5 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K970887Blood Flow AnalyzerParadigm Medical Industries, Inc.19971

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K970887 (Paradigm Medical Industries, Inc., 1997) has gone furthest, with 1 descendant of its own.

How does its category compare?

All HKX devices

HKX Tonometer, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HKX

1in 2025

2008: 22009: 12010: 12011: 12012: 12015: 12017: 12018: 12019: 32023: 12025: 1
2007high 3 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HKX

290in 2019

2019: 290 days median
2007high 290 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HKX

No recall names HKX since 2007.

Adverse event reports per year · HKX

1in 2015

2008: 12010: 12015: 1
2007high 1 (2008) · low 0 (2007)2025

MAUDE reports naming product code HKX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20082—01
20091—00
20101—01
20111—00
20121—00
20130—00
20140—00
20151—01
20160—00
20171—00
20181—00
2019329000
20200—00
20210—00
20220—00
20231—00
20240—00
20251—00
20260—0—

More from Ocular Blood Flow Laboratories, Inc.

2 FDA decisions under this applicant name. See the company

  • K864959Obf Model 112 Vacuum Cup SystemOcular Blood Flow Laboratories, Inc. · 1987

Recent decisions in HKX

The HKX category page

  • K253039Auto Kerato-Refracto Tonometer TRK-3 OmniaTopcon Corporation · 2025
  • K223739VS Tabletop TonometerMedimaging Integrated Solution, Inc. · 2023
  • K190382Intraocular Pressure Tonometer EASYTONCompany Elamed · 2019
  • K181260MiiS Horus Scope DPT 100Medimaging Integrated Solution, Inc (Miis) · 2019
  • K181143Keeler TonoCare TonometerKeeler Instruments, Inc. · 2019

https://510kreport.com/device/K873422 · printed Nov 4, 2026

Cite this page

510(k) Report. “K873422: Obf Model 115 Computer Tonometer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K873422

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026