510(k) Report

510(k) · Cleared

Cleared

Disposable Hypodermic Monoplar Needle Recording

K924277510(k) TraditionalCleared Dec 7, 1994834-day reviewClass II21 CFR 886.1640

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

Chalgren Enterprises, Inc. · HLT Preamplifier, Ac-Powered, Ophthalmic

Cleared on Dec 7, 1994 after an 834-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Dec 7, 1994
Review
834 days
Class
Class II
Product code
HLT
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K924277Source: FDA 510(k) database · How lineage is built

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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.

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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

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.

How does its category compare?

All HLT devices

HLT Preamplifier, Ac-Powered, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HLT

FDA has decided no HLT device since 2007.

Median 510(k) review, days · HLT

Too few HLT 510(k)s in any year since 2007 to give a median.

Recalls per year · HLT

No recall names HLT since 2007.

Adverse event reports per year · HLT

No MAUDE report names HLT since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Chalgren Enterprises, Inc.

21 FDA decisions under this applicant name. See the company

  • K982950Fine Wire Electrode Mmodel Numbers 221-14-730, 221-24-730, 221-14-550, 221-24-550Chalgren Enterprises, Inc. · 1999
  • K960591RE-Usable Bipolar Concentric Needle (237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-XXX-24STPChalgren Enterprises, Inc. · 1996
  • K955335Disposable Hypodermic Monopolar Needle Recording ElectrodeChalgren Enterprises, Inc. · 1996
  • K953354Emg Disc Recording ElectrodeChalgren Enterprises, Inc. · 1996
  • K953356Emg Recording Ring ElectrodeChalgren Enterprises, Inc. · 1996

Recent decisions in HLT

The HLT category page

  • K921815Tomey PE-300 Portable ErgTomey Corporation USA · 1992
  • K841293Panoramic Loupes - VariousKeller Instruments, Inc. · 1984
  • K781543OrbiographSonometrics Systems, Inc. · 1978

https://510kreport.com/device/K924277 · printed Nov 4, 2026

Cite this page

510(k) Report. “K924277: Disposable Hypodermic Monoplar Needle Recording.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K924277

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