510(k) Report

FDA applicant

Ultra Seal Corporation

New Paltz, NY1 decision2010–20100 recalls

FDA records 1 decision for Ultra Seal Corporation (New Paltz, NY) in 2010: 1 510(k) clearance. All are in product code KMJ (Lubricant, Patient). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

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

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Ultra Seal Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Ultra Seal Corporation by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ultra Seal Corporation’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • KMJLubricant, Patient1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K101522Ultra Seal Sterile Lubricating JellyUltra Seal Corporation · 2010

The one decision as Ultra Seal Corporation →

Other applicant names beginning “Ultra”

FDA records each applicant name separately; these may or may not be the same firm.

Ultra Quest Diagnostics, Inc. 3Ultra Tan Intl. AB 2Ultra Electronics Limited Precision Air & Land SY 1Ultra-Light Corp. 1