510(k) Report

510(k) · Cleared

Cleared

Camera Cover with Tear Tip

K940152510(k) TraditionalCleared Oct 28, 1994298-day reviewClass I21 CFR 876.1500

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

Hydro-Med Products, Inc. · FEM Accessories, Photographic, For Endoscope (Exclude Light Sources)

Cleared on Oct 28, 1994 after a 298-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Oct 28, 1994
Review
298 days
Class
Class I
Product code
FEM
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K940152Source: 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.

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

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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?

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 FEM devices

FEM Accessories, Photographic, For Endoscope (Exclude Light Sources): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FEM

FDA has decided no FEM device since 2007.

Median 510(k) review, days · FEM

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

Recalls per year · FEM

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FEM

116in 2025

2008: 32010: 22012: 12013: 62014: 82015: 52016: 92017: 142018: 152019: 222020: 542021: 472022: 1092023: 1312024: 1082025: 116
2007high 131 (2023) · low 0 (2007)2025

MAUDE reports naming product code FEM, 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
20080—03
20090—00
20100—02
20110—10
20120—01
20130—06
20140—08
20150—05
20160—09
20170—014
20180—015
20190—022
20200—054
20210—047
20220—0109
20230—0131
20240—0108
20250—0116
20260—0—

More from Hydro-Med Products, Inc.

13 FDA decisions under this applicant name. See the company

  • K944198Surgical Microscope DrapeHydro-Med Products, Inc. · 1994
  • K940151Ultrasound Probe DrapeHydro-Med Products, Inc. · 19941 recall
  • K934630Universal Video/Laser Arm DrapeHydro-Med Products, Inc. · 1994
  • K923099X-Ray DrapesHydro-Med Products, Inc. · 1992
  • K863872Tamper HamperHydro-Med Products, Inc. · 1987

Recent decisions in FEM

The FEM category page

  • K812542Polaroid Instant EndocameraPolaroid Corp. · 1981
  • K812201Photographic EquipmentReznik Instruments · 1981
  • K792512Polaroid Land Camera for EndoscopyPolaroid Corp. · 1979

https://510kreport.com/device/K940152 · printed Nov 4, 2026

Cite this page

510(k) Report. “K940152: Camera Cover with Tear Tip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K940152

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